Automated microbial detection apparatus

ABSTRACT

A method and automated apparatus for rapid non-invasive detection of a microbial agent in a test sample is described herein. The apparatus may include one or more means for automated loading, automated transfer and/or automated unloading of a specimen container. The apparatus also includes a detection system for receiving a detection container, e.g., container or vial, containing a biological sample and culture media. The detection system may also include one or more heated sources, holding structures or racks, and/or a detection unit for monitoring and/or interrogating the specimen container to detect whether the container is positive for the presence of a microbial agent therein. In other embodiment, the automated instrument may include one or more, bar code readers, scanners, cameras, and/or weighing stations to aid in scanning, reading, imaging and weighing of specimen containers within the system.

CROSS REFERENCE TO RELATED APPLICATION

This application claims the benefit of: (1) U.S. Provisional PatentApplication No. 61/216,339, entitled “System for Combining aNon-invasive Rapid Detection Blood Culture System with an InvasiveMicrobial Separation and Characterization System”, filed May 15, 2009;(2) U.S. Provisional Patent Application No. 61/277,862, entitled“Automated Loading Mechanism for Microbial Detection Apparatus”, filedSep. 30, 2009; and (3) U.S. Provisional Patent Application No.61/337,597, entitled “Automated Microbial Detection Apparatus”, filedFeb. 8, 2010; all of which are incorporated herein.

FIELD OF THE INVENTION

The present invention is directed to an automated system for detectingthe presence of a microbial agent or microorganism in a test sample suchas a biological sample. Moreover, the automated system builds upon andimproves existing detection systems for processing specimen containers,such as culture bottles.

BACKGROUND OF THE INVENTION

The detection of pathogenic microorganisms in biological fluids shouldbe performed in the shortest possible time, in particular in the case ofsepticemia for which the mortality remains high in spite of the broadrange of antibiotics which are available to doctors. The presence ofbiologically active agents such as a microorganism in a patient's bodyfluid, especially blood, is generally determined using blood culturebottles. A small quantity of blood is injected through an enclosingrubber septum into a sterile bottle containing a culture medium, and thebottle is then incubated at 37° C. and monitored for microorganismgrowth.

Instruments currently exist on the market in the U.S. that detect thegrowth of a microorganism in a biological sample. One such instrument isthe BacT/ALERT® 3D instrument of the present assignee bioMérieux, Inc.The instrument receives a blood culture bottle containing a bloodsample, e.g., from a human patient. The instrument incubates the bottleand periodically during incubation an optical detection unit in theincubator analyzes a colorimetric sensor incorporated into the bottle todetect whether microbial growth has occurred within the bottle. Theoptical detection unit, bottles and sensors are described in the patentliterature, see U.S. Pat. Nos. 4,945,060; 5,094,955; 5,162,229;5,164,796; 5,217,876; 5,795,773; and 5,856,175, the entire content ofeach of which is incorporated by reference herein. Other prior art ofinterest relating generally to the detection of microorganisms in abiological sample includes the following patents: U.S. Pat. No.5,770,394, U.S. Pat. No. 5,518,923; U.S. Pat. No. 5,498,543, U.S. Pat.No. 5,432,061, U.S. Pat. No. 5,371,016, U.S. Pat. No. 5,397,709, U.S.Pat. No. 5,344,417 and its continuation U.S. Pat. No. 5,374,264, U.S.Pat. No. 6,709,857; and U.S. Pat. No. 7,211,430, the entire content ofeach of which is incorporated by reference herein.

Substantial, and potentially life saving, clinical benefits for apatient are possible if the time it takes for detection of a microbialagent in a blood sample and reporting the results to a clinician couldbe reduced. A system that meets this need has heretofore eluded the art.However, such rapid detection of a microbial agent in a biologicalsample such as a blood sample is made possible by apparatus describedherein.

The disclosed system and methods combines a detection system operativeto detect a container containing a test sample (e.g., a biologicalsample) as being positive for microbial agent presence. The systems andmethods of this disclosure have the potential to: (a) reduce laboratorylabor and user errors; (b) improve sample tracking, traceability andinformation management; (c) interface to laboratory automation systems;(d) improve work-flow and ergonomics; (e) deliver clinically relevantinformation; (f) faster results.

Many further advantages and benefits over the prior art will beexplained below in the following detailed description.

SUMMARY OF THE INVENTION

An automated system and instrument architecture is described below thatprovides for automated detection of the presence of a microbial agent(e.g., a microorganism) in a test sample contained within a specimencontainer. In one embodiment, the automated detection apparatus is anautomated culture instrument for detecting the growth of a microbialagent contained in, or suspected of being contained in, a test sample,wherein the test sample is cultured within a specimen container, e.g., aculture bottle.

The automated detection system receives a specimen container (e.g., aculture bottle), containing a culture media and a test sample (e.g., ablood sample), suspected of containing a microorganism therein. Thedetection system comprises a housing, a holding structure and/oragitation assembly for holding and/or agitating the specimen containerto promote or enhance microorganism growth therein, and optionally mayfurther contain one or more heating elements to provide a heatedenclosure or incubation chamber. The automated detection system alsocomprises one or more detection units that determine whether a containeris positive for the presence of a microbial agent in the test sample.The detection unit may include the features of U.S. Pat. Nos. 4,945,060;5,094,955; 5,162,229; 5,164,796; 5,217,876; 5,795,773; and 5,856,175, orit may include other technology for detecting the presence of amicrobial agent in the test sample. Containers (e.g., bottles) in whicha microbial agent is present are termed “positive” herein.

In one embodiment, the disclosed apparatus is an automated detectionsystem for rapid non-invasive detection of microorganism growth in aspecimen sample, comprising one or more of: (a) a sealable specimencontainer having an internal chamber with a culture medium disposedtherein for culturing any microorganisms that may be present in saidspecimen sample; (b) a housing enclosing an interior chamber (e.g., anincubation chamber) therein for promoting and/or enhancing microorganismgrowth; (c) a holding structure or holding rack, optionally comprisingan agitation assembly (e.g., a holding and agitation rack) containedwithin said housing and comprising a plurality of wells for holding saidcontainers, said agitation assembly operable for agitating said specimencontainers to promote and/or enhance microorganism growth; (d) acontainer locator device, and wherein said container locator device isoperable to move said specimen container to one or more containerwork-flow stations; (e) an automated loading mechanism for automatedloading of a specimen container into said interior chamber; (f) anautomated transfer mechanism within said housing for automated transferof said specimen container from an entrance location to said holdingstructure and/or for automated transfer of said specimen containerwithin said housing; and/or (g) a detection unit within said housing formonitoring, and/or detecting microorganism growth within said specimencontainer.

In another embodiment, a method for detection of microorganism growth inan automated detection system is disclosed; the method comprising one ormore of the following steps: (a) providing a specimen containercomprising a culture medium for promoting and/or enhancing growth ofsaid microorganism; (b) inoculating said specimen container with a testsample to be tested for the presence of a microorganism; (c) providingan automated detection apparatus for the detection of microorganismgrowth, said apparatus comprising a housing enclosing an incubationchamber therein for promoting and/or enhancing microorganism growth, aholding structure located within said housing, said holding structurecomprising a plurality of wells for holding one or more of said specimencontainers, an automated loading mechanism for automated loading of saidspecimen container into said automated detection apparatus, a containerlocator device for moving said specimen container to one or morecontainer work-flow stations, an automated transfer mechanism forautomated transfer of said specimen container within said housing tosaid holding structure, and a detection unit for detecting one or moreby products of microorganism growth within said specimen container; (d)loading said inoculated specimen container into said detection systemusing the automated loading mechanism; (e) transferring said specimencontainer to a holding structure located within said detection systemusing the automated transfer mechanism; (f) incubating said specimencontainer within said incubation chamber; and/or (g) periodicallymonitoring said specimen container for detection of said one or more byproducts of microorganism growth, wherein said specimen container isdetermined as positive for microorganism growth by the detection of saidone or more by products of microorganism growth therein.

In still another embodiment, the automated detection system may containone or more work-flow stations for obtaining one or more measurements orreadings of a specimen container, thereby providing information, suchas, container type, container lot number, container expiration date,patient information, sample type, test type, fill level, weightmeasurement, etc. For example, the automated detection system maycontain one or more of the following stations: (1) a bar code readingstation; (2) a container scanning stations; (3) a container imagingstation; (4) a container weighing station; (5) container pick-upstation; and/or (6) a container transfer station. In accordance withthis embodiment, the automated detection system may further comprise acontainer management device or container locator device for movingand/or locating a specimen container among various stations of thedetection system.

In yet another embodiment, the detection system may further comprise aretention feature for retaining a container in a holding structure,comprising: (a) provided a holding structure comprising one or moreholding wells for holding one or more containers therein; (b) a cantedcoiled spring located adjacent the holding wells; and (c) a holdingplate comprising a v-shaped groove located adjacent the canted coiledspring for retaining the canted coiled spring adjacent to the holdingwells; wherein the canted coiled spring is operable to hold the one ormore containers in said holding well.

BRIEF DESCRIPTION OF THE FIGURES

The various inventive aspects will become more apparent upon reading thefollowing detailed description of the various embodiments along with theappended drawings, in which:

FIG. 1 is a perspective view of an automated system for rapidnon-invasive detection of a microbial agent in a test sample. As shown,the system includes an automated loading mechanism.

FIG. 2 is a perspective view of the detection system of FIG. 1, showinga close-up view of the automated loading mechanism.

FIG. 3 is a perspective view of the detection system of FIG. 1, whichshows an automated loading mechanism and a lower drawer that opens toreveal a waste container for containers that tested negative forpresence of a microbial agent.

FIG. 4 is a side view of one of the specimen containers processed in thedetection system of FIG. 1-3. While the detection container can take avariety of forms, in one embodiment it is configured as a blood culturebottle.

FIG. 5A is a side elevation view of one configuration of the detectionsystem of FIG. 1.

FIG. 5B is a perspective view of the detection system shown in FIG. 5A,with the upper and lower doors open showing the interior chambers andracks for holding multiple containers of the type shown in FIG. 4.

FIG. 6 is a perspective view of the transfer mechanism shown in FIGS. 5Aand 5B, showing the horizontal and vertical support rails. Also shownare first and second rotational mechanisms, which are operable to rotatethe transfer mechanism about one or more axes.

FIG. 7A is a perspective view of the robotic head and vertical supportrail shown in FIGS. 5A and 5B. As shown in FIG. 7A, the robotic head isposition in a vertical orientation, such that a specimen container heldwithin the robotic head is also in a vertical orientation.

FIG. 7B is another perspective view of the robotic head and verticalsupport rail shown in FIGS. 5A and 5B. As shown in FIG. 7B, the robotichead is positioned in a horizontal orientation, such that the containerheld within the robotic head is also in a horizontal orientation.

FIGS. 8A-C shows a time-elapsed loading of a specimen container into theholding chamber of the robotic head shown in FIGS. 5A and 5B. As shownin FIG. 8A, the gripping mechanism grips the top or cap of thecontainer. FIG. 8B shows the container in an intermediate position inthe loading process. FIG. 8B, shows the container after being loadedinto the robotic head.

FIGS. 9A and 9B are perspective and side views, respectively, of analternative configuration of the detection system of FIGS. 1-3 and5A-5B, with the upper and lower doors open showing an alternativeconfiguration of the container holding structures. In the embodiment ofFIGS. 9A and 9B, the racks are arranged in a drum or cylinder-typeconfiguration.

FIG. 10 is a perspective view of another configuration of the automatedloading mechanism, showing a first conveyor belt operable in ahorizontal plane and a second conveyor belt operable in a verticalplane.

FIG. 11 is a perspective view of yet another configuration of theautomated loading mechanism, showing a first conveyor belt operable in ahorizontal plane and a second conveyor belt having a plurality ofpaddles and operable in a vertical plane.

FIG. 12 is a perspective view of a casing and cover provided with anautomated loading mechanism.

FIG. 13 is a perspective view of one embodiment of an automated loadingmechanism shown isolated from the detection system. In accordance withthis embodiment, the automated loading mechanism comprises a loadingstation or area, a transport mechanism and an entrance location, for thefully automated loading of a specimen container. A portion of one sideof the loading area has been removed to show additional details of theautomated loading mechanism of this embodiment.

FIG. 14 is another perspective view of the automated loading mechanismshown in FIG. 14. The container loading area is shown as a see throughfeature to reveal other features of the automated loading mechanism, asdescribed herein.

FIG. 15 is a close up perspective view of the drum-like loadingmechanism, vertical chute, locating device and system transfer device inFIG. 14. The drum-like loading mechanism, vertical chute, locatingdevice and system transfer device are shown isolated from the detectionsystem.

FIG. 16 is a cross-sectional view of the automated loading mechanismshown in FIGS. 14-15. More specifically, FIG. 16 is a cross-sectionalview of the drum-like loading mechanism and vertical chute showing aspecimen container falling through the chute. As shown in FIG. 16, thetop or cap of the specimen container is held in place briefly by thetapered ledge as the bottom of the container falls through the chute,thereby up-righting the specimen container.

FIG. 17 is a perspective view of the automated detection apparatuscomprising the automated loading mechanism shown in FIG. 14. Thecontainer loading area of the automated loading mechanism is shown in auser accessible location on the front of an automated system for rapidnon-invasive detection of a microbial agent. The automated detectionsystem and the container loading area are shown with side panels removedand/or as see through features to reveal other features, as describedherein.

FIG. 18 is a perspective view of the automated detection apparatuscomprising an alternative loading mechanism. The container loading areaof the automated loading mechanism is shown in a user accessiblelocation on the front of an automated system for rapid non-invasivedetection of a microbial agent. The automated detection system and thecontainer loading area are shown with side panels removed and/or as seethrough features to reveal other features, as described herein.

FIG. 19 is a side view of the lower portion of the automated system forrapid non-invasive detection of a microbial agent shown in FIG. 17. Theautomated detection system is shown with side panel removed to revealother features of the system, as described herein.

FIG. 20 is a perspective view of the holding structure and automatedtransfer mechanism shown in FIGS. 17-19. As shown, in this embodiment,the automated transfer mechanism comprises a lower horizontal support, avertical support, a pivot plate and a robotic head for transferring aspecimen container within a detection apparatus. For clarity, theholding structure and automated transfer mechanism are shown isolatedfrom the detection apparatus.

FIGS. 21A-B are perspective views of the pivot plate and robotic head ofthe automated transfer mechanism shown in FIG. 20. The robotic head isshown with a cross-sectional view of the gripping mechanism and specimencontainer to reveal the features of the gripping mechanism. As shown inFIG. 21A, the robotic head is located at a first end of the pivot platedand in a horizontal orientation, such that the specimen container isalso orientated in a horizontal orientation. In FIG. 21B, the robotichead is shown located at a second end of the pivot plate and in avertical orientation, such that the specimen container is alsoorientated in a vertical orientation.

FIG. 22 is a perspective view of an alternative configuration of theautomated detection apparatus showing a user interface, a status screen,a locator device cover and two positive container ports.

FIG. 23 is a perspective view showing another design configuration ofthe detection apparatus. As shown in FIG. 23, the detection systemcomprises a first detection apparatus and a second detection instrument.

FIG. 24 is a perspective view of yet another embodiment of the automateddetection system. As shown, the automated detection system comprises afirst detection apparatus having an automated loading mechanism and asecond or down-stream detection apparatus linked or “daisy-chained” tothe first detection apparatus, as described herein.

FIGS. 25A-C show a time-elapsed pusher arm mechanism for pushing aspecimen container from a first detection apparatus to a second ordown-stream detection apparatus.

FIG. 26 shows a perspective view of the holding structure and agitationassembly shown isolated from the detection system.

FIG. 27A is a perspective view of a rack holding structure and retentionfeature for holding a specimen container securely within the rackholding structure.

FIG. 27B shows a cross-sectional view of the rack holding structure andretention feature shown in FIG. 27A.

FIG. 27C is a top cross-sectional view of the rack holding structure andretention feature of FIG. 27A, showing a schematic representation of acanted coiled spring.

FIG. 28A-B show first and second perspective views of a carrier forcarrying a plurality of specimen containers to the detection apparatus.As shown, the carrier comprises a plurality of holding wells for holdinga plurality of specimen containers. FIG. 28A also shows two opposedgripping features or handles and a release mechanism for releasing theplurality of specimen containers at the loading station, as describedherein.

FIG. 29 shows a perspective view of another possible configuration forthe detection system. As shown in FIG. 29, the detection system includesa release mechanism for releasing one or more specimen containers fromthe carrier shown in FIGS. 28A-B.

FIG. 30 is a flow chart showing the steps performed in the operation ofthe detection system.

DETAILED DESCRIPTION OF THE INVENTION

An automated system or instrument for non-invasive detection of thepresence of a microbial agent (e.g., a microorganism) in a test samplecontained within a sample container, e.g., a culture bottle, isdescribed herein. One embodiment of the automated system or instrumentis described herein in conjunction with FIGS. 1-8C. Other possibleembodiments and design alternatives are shown in conjunction with FIGS.9A-30, and described herein. The automated system can include one ormore of the following features: (1) a housing, enclosing an interiorchamber; (2) an automated loading mechanism for loading one or morecontainers into the interior chamber of the system; (3) an automatedcontainer management mechanism or locator device for moving or locatinga container among various work-flow stations within the system; (4) anautomated transfer mechanism, for transfer of a container within thesystem; (5) one or more container holding structures for holding aplurality of specimen containers, optionally provided with an agitationassembly; (6) a detection unit for detection of microbial growth; and/or(7) a mechanism for automated unloading of a specimen container from thesystem. In order to better appreciate how the illustrated embodiment ofthe detection system operate, this specification may describe theautomated detection apparatus in the context of a particular detectioninstrument (a blood culture instrument) and specimen container (a bloodculture bottle). However, persons skilled in the art will readilyappreciate that the detection apparatus can be practiced in otherembodiments, that variations from the specific embodiments disclosedherein can be arrived at to suit particular implementations, and thattherefore the present description of a preferred embodiment and bestmode for practicing the invention is provided by way of illustration andnot limitation.

System Overview

An automated detection system 100 (for example, as illustrated in FIGS.1-3 and 5A-5B) is described herein that provides a new architecture andmethod for automated detection of a microbial agent (e.g., amicroorganism) that may be present in a test sample or specimen sample.In general, any known test sample (e.g., a biological sample) can beused. For example, the test sample can be a clinical or non-clinicalsample suspected of containing one or more microbial agents. Clinicalsamples, such as a bodily fluid, include, but are not limited to, blood,serum, plasma, blood fractions, joint fluid, urine, semen, saliva,feces, cerebrospinal fluid, gastric contents, vaginal secretions, tissuehomogenates, bone marrow aspirates, bone homogenates, sputum, aspirates,swabs and swab rinsates, other body fluids, and the like. Non-clinicalsamples that may be tested include, but not limited to, foodstuffs,beverages, pharmaceuticals, cosmetics, water (e.g., drinking water,non-potable water, and waste water), seawater ballasts, air, soil,sewage, plant material (e.g., seeds, leaves, stems, roots, flowers,fruit), blood products (e.g., platelets, serum, plasma, white blood cellfractions, etc.), donor organ or tissue samples, biowarfare samples, andthe like. In one embodiment, the biological sample tested is a bloodsample.

Referring now to the Figures, several configurations are possible forthe detection system 100. As shown, for example, in FIGS. 1-3 and 5A-5B,the automated detection system 100 comprises a housing 102 and one ormore automated mechanisms for loading (see, e.g., 200, FIG. 1), movingor locating (not shown), transferring (see, e.g., 650, FIGS. 5A-5B),agitating (not shown) and/or unloading of specimen containers 500 withinor from the detection system 100. The housing 102 comprises front andback panels 104A and 104B, opposing side panels (e.g., left-side andright-side panels) 106A and 106B, a top or roof panel 108A and a bottomor floor panel 108B, which form an enclosure, enclosing an interiorchamber 620 (see, e.g., FIGS. 5A-5B) of the detection system 100. In oneembodiment, the interior chamber 620 of the detection system 100 is aclimate-controlled chamber (e.g., a temperature-controlled incubationchamber wherein the temperature is maintained at approximately 37° C.)to promote or enhance microbial growth. As shown in FIGS. 1-3, thehousing also may include a first port or container entrance location110, a second port or misread/error location 120, a third port orpositive container exit location 130, a lower access panel 140 (FIG. 1)or drawer 142 (FIG. 3), and/or a user interface display 150. As known inthe art, the lower access panel 140 or drawer 142 may include a handle144. Also as shown in FIG. 1, the housing 102 may also comprise upperand lower sections 160 and 170, optionally each comprising an operabledoor (i.e., upper and lower doors) 162 and 172 (see, e.g., FIG. 5B). Theupper door 162 and lower door 172 are operable to allow access to theinterior chamber 620 of the detection system 100. However, as one ofskill in the art would appreciate other design configurations arepossible. For example, in another possible embodiment, the entire frontpanel may comprise a single operable door (not shown).

In one design possibility, as shown for example in FIGS. 1-3, the lowersection 170 may have a larger profile or footprint than the uppersection 160. In accordance with this embodiment the housing of thelarger lower section 170 forms a shelf 180 on a top surface of the lowersection 170 and adjacent to or in front of the upper section 160. Thisshelf 180 may provide a user workstation and/or workflow access pointsto the detection system 100. Furthermore, the shelf 180 may comprise anautomated loading means or mechanism 200. The shelf 180 may furtherprovide access locations for the first port or container entrancelocation 110, the second port or misread/error location 120, and thethird port or positive container exit location 130.

In one embodiment, as shown for example in FIGS. 1-3 and 5A-5B, thedetection system 100 may comprise an automated loading mechanism 200,for the automated loading of a specimen container 500 into the detectionsystem 100. The automated loading mechanism 200 may comprise a containerloading station or area 202, a transport mechanism 204 and a first portor container entrance location 110. In operation, a user or techniciancan place one or more specimen containers 500 (see, e.g., FIG. 4) at thecontainer loading station or area 202. A transport mechanism 204, forexample, a conveyor belt 206, will transport the specimen container tothe first port or container entrance location 110, and subsequentlythrough the entrance location 110 and into the detection system 100,thereby loading the container into the system. The automated loadingmechanism 200 is described in greater detail herein.

As one of skill in the art would appreciate, other designs may beemployed for the automated loading mechanism and are described elsewhereherein. For example, alternative automated loading mechanisms are shownin FIGS. 10-16. In one embodiment, as shown in FIGS. 13-16, and asdescribed in greater detail herein, the detection system 100 may employa container loading area or reservoir 302 and a drum-like loading device308 for the automated loading of a specimen container into the detectionsystem 100.

In another embodiment, as shown for example in FIGS. 14-15 and 18, theautomated detection system 100 may contain one or more work-flowstations 404 for obtaining one or more measurements, readings, scansand/or images of a specimen container, thereby providing information,such as, container type, container lot number, container expirationdate, patient information, sample type, test type, fill level, weightmeasurement, etc. Furthermore, the one or more work-flow stations 404may comprise one or more container management stations, such as, acontainer pick-up station or a container transfer station. For example,the automated detection system may contain one or more of the followingwork-flow stations: (1) a bar code reading station; (2) a containerscanning stations; (3) a container imaging station; (4) a containerweighing station; (5) container pick-up station; and/or (6) a containertransfer station. In accordance with this embodiment, the detectionsystem 100 may further have a container management means or containerlocator device 400, as shown, for example, in FIGS. 13-15, 18 and 24. Inoperation, the container management device or locator device 400,operates to move or otherwise locate a specimen container 500 to one ormore work-flow stations 404. In one design configuration, one or more ofthe work-flow stations are included within the housing 102 of thedetection system 100. In one embodiment, as best shown in FIGS. 14-15,the drum or drum-like loading device 308 and vertically orientated chute332 of automated loading mechanism 300 can operated to deposit or placea specimen container into a locator well 402, as described elsewhereherein. In another embodiment, as best shown, in FIGS. 18 and 24, thetransport mechanism 204, or conveyor belt 206, of automated loadingmechanism 200 can operate to deposit or place a specimen container intoa locator well 402, as described elsewhere herein. As known in the art,the detection system 100 may further comprise one or more guide rails(not shown) to guide the specimen container into the locator well 402.In accordance with both of these embodiments, the container managementdevice or locating device 400 can then rotate to move or locate thespecimen container among various work-flow stations 404 within thesystem, such as for example, a bar code reading station, a containerscanning stations, a container imaging station, a container weighingstation, container pick-up station, and/or a container transfer station.The container management device or locator device 400 is described ingreater detail herein.

As shown, for example, in FIGS. 5A-8C the detection system 100 may alsocomprise an automated transfer means or mechanism 650 for transferringthe specimen containers 500 within the housing 102 of the detectionsystem 100. For example, the transfer mechanism 650 may transfer thespecimen container 500 from an entrance location or port 110 (see, e.g.,FIGS. 1-3), into the interior chamber 620 of the detection system 100,and place the container 500 into one of the receiving structures orwells 602 contained in one of a plurality of holding structures or racks600. In another embodiment, the transfer mechanism 650 may also be usedto rearrange, transfer or otherwise manage specimen containers 500within the system. For example, in one embodiment, the transfermechanism 650 can be used to transfer a specimen container 500, detectedas positive for microbial growth (referred to herein as a “positive”container), from the holding structure or rack 600 to a positivecontainer location, such as a positive container exit location or port130 (see, e.g., FIG. 1) where a user or technician can easily remove thepositive container 500 from the detection system 100. In anotherembodiment, the transfer mechanism 650 can be used to transfer acontainer 500 determined as negative for microbial growth after adesignated time has passed (referred to herein as a “negative”container), from the holding structure or rack 600 to a negativecontainer location within the system (e.g., a negative container wastebin 146 (see, e.g., FIG. 1)) where a user or technician can easilyaccess the waste bin 146 for removal and disposal of the container 500.As one of skill in the art would appreciate, other designs may beemployed for the automated transfer mechanism and are describedelsewhere herein. For example, another design configuration is describedherein in conjunction with FIGS. 17-21B.

The detection system 100 will also include a means for detecting growth(e.g., a detection unit) in the specimen containers 500 (see, e.g., FIG.27). In general, any known means in the art for detecting microbialgrowth in a container can be used. For example, as is well known in theart, each holding station or rack 600 may contain a linear scanningoptical system that has the capability of non-invasive monitoring ofmicroorganism growth in each specimen container 500. In one embodiment,the optical system can interrogate a sensor (e.g., a Liquid EmulsionSensor (LES) sensor) 514 (see, e.g., FIG. 4) in the containers 500,thereby detecting for microorganism growth within the container.

The detection system 100 may also include an automated unloadingmechanism for the unloading of “positive” and/or “negative” specimencontainers 500. This automated unloading mechanism can operate to ensurethat once a “positive” or “negative” reading has been made for eachspecimen container 500, the container 500 is removed from the containerreceiving structures or wells 602 (see, e.g., FIGS. 5A and 5B), makingroom for another container to be loaded into the detection system 100,thereby increasing system through-put.

Specimen Container

The specimen container 500, shown for example in FIGS. 4 and 27B, andother figures, is shown in the form of a standard culture bottle (e.g.,a blood culture bottle). However, the description of a culture bottle(e.g., a blood culture bottle) is offered by way of example and notlimitation. As shown in FIG. 4, the specimen container 500 comprises atop portion 502, a body 504, and a base 506. The container 500 mayinclude a bar code label 508 for automated reading of the container 500within either the detection system or off-line equipment. As shown inFIGS. 4 and 27B, the top portion 502 of the container 500 typicallycomprises a narrow portion or neck 510 through which an opening 516extends to provide communication with the interior chamber 518 of thecontainer. As shown in FIG. 27B, the container also includes a closuredevice 512 (e.g., a stopper), optionally having a pierceable septum andmay also have a sensor 514 (e.g., an LES sensor) formed or placed in thebottom of the container 500 for purposes of colorimetric detection ofthe presence of microbial growth in the container 500. The configurationof the container 500 is not particular important and the inventivesystem and methods can be adapted to a variety of containers designedfor culturing a test sample (e.g., a biological test sample). Containers500 of the type shown in FIGS. 4 and 27B are well known in the art anddescribed in the patent literature cited in the Background section ofthis document.

In one embodiment, the specimen containers 500 are inoculated with atest sample (e.g., a clinical or non-clinical biological sample) and areloaded/unloaded into/out of the detection system 100. The container 500may further comprise a growth or culture medium (not shown) forpromoting and/or enhancing microbial or microorganism growth. The use ofa growth or culture media (or medium) for the cultivation ofmicroorganisms is well known. A suitable growth or culture mediumprovides the proper nutritional and environmental conditions for growthof microorganisms and should contain all the nutrients required by themicroorganism which is to be cultivated in the specimen container 500.After a sufficient time interval to allow natural amplification ofmicroorganisms (this time interval varies from species to species), thecontainer 500 is tested within the detection system 100 for the presenceof microbial or microorganism growth. The testing may occur continuouslyor on a periodic basis so that the container can be determined aspositive for microorganism growth as soon as possible.

In one embodiment, once a container 500 is detected as positive in thedetection system 100, the system will notify the operator through anindicator 190 (e.g., a visual prompt), and/or via a notification at theuser interface display 150, or by other means.

Automated Loading Means or Mechanism

The detection system 100 may include a means or mechanism for automatedloading of a specimen container 500 into the detection system 100. Inone embodiment, as shown for example in FIGS. 1-3 and 5A-5B, theautomated loading mechanism 200 may comprise a container loading stationor area 202, a transport mechanism 204 and an entrance location or port110. However, as would be appreciated by one of skill in the art, theautomated loading mechanism can take on many different configurations.For example, another design configuration of an automated loadingmechanism 300 is described herein in conjunction with FIGS. 13-16. Thevarious design configurations described herein are by way ofillustration and not limitation. The automated loading mechanisms shownherein (e.g., FIGS. 1-3, 5A-5B and 13-16) are shown schematically andthe parts are not to scale.

A user or technician can transport one or more specimen containers 500to the detection system 100 by any known means and place the containers500 at a container loading station or area 202. For example, in oneembodiment, a user or technician can use a carrier designed to transporta plurality of specimen containers to the loading station or area 202 ofthe detection system 100.

One possible carrier design is shown in FIGS. 28A and 28B. As shown inFIGS. 28A and 28B, the carrier 350 comprises a body 351 having top andbottom surfaces 352A and 352B, respectively, front and back surfaces354A and 354B, respectively, opposing side surfaces 356A and 356B (e.g.,a right side surface and left side surface), respectively, and a pair ofopposing user handles 358A and 358B, attached to said opposing sidesurfaces 356A, 356B. The body further comprises a plurality of throughholes 360, each configured to hold a single specimen container 500therein. The body 351 may also comprise a slide plate 362 operablewithin a slide joint 364 to slide back-and-forth (see, e.g., arrow 366in FIG. 28A) between a “closed” position, to retain the specimencontainers 500 loaded within the carrier 350, and an “open” position, torelease the specimen containers 500 from the carrier 350, and depositthem onto or into an automated loading mechanism. The slide joint 364may further comprise a spring, or like means, for locking the slideplate 362 in the “closed” position during transport by a user to adetection system.

As shown in FIGS. 28A-29, the carrier 350 may further comprise a pair ofalignment arms 368A and 368B and a release tab 370 operable with arelease mechanism 372 for releasing the specimen containers 500 at anautomated loading mechanism 200 of a detection system 100. The releasemechanism 372 comprises a pair of slots 374 that correspond to the pairof alignment arms 368A and 368B, to ensure the carrier 350 is properlyaligned at the loading station or area 202 for depositing the specimencontainers 500, and a release bar 376. In operation, a techniciantransports a carrier 350, containing one or more specimen containers500, to the automated loading mechanism 200 and presses the carrier 350against the release bar 376, with the alignment arms 368A and 368Baligned with the corresponding slots 374 of the release mechanism 372.By pressing the carrier 350 against the release bar 376, the release tab370 is pushed in or depressed, thereby moving the slide plate 362 to the“open” position and allowing the specimen containers 500 to fall out ofthe through holes 360 and onto the loading station or area 202. Thetechnician can then lift the carrier 350 upward until the carrier body351 and plurality of through holes 360 clear the specimen containers500, thereby depositing the containers at the automated loadingmechanism 200 for automated loading into the detection system 100. Asone of skill in the art would appreciate other design configurations arepossible.

As shown in FIGS. 1-3, the loading station or area 202 is typically aneasily accessible location or area of the automated loading mechanism200 where a user or technician can place one or more specimen containers500 for loading into the detection system 100. Once at the loadingstation 202, the containers 500 will be transported, using a transportmechanism 204, from the loading station or area 202 to an entrancelocation or port 110, and subsequently through the entrance location orport 110 and into the detection system 100. Accordingly, a user ortechnician can simply place one or more specimen containers 500 at theloading station or area 202 and walk away, while the containers 500 areautomatically loaded into the detection system 100. Once the specimencontainers 500 have been transported into the system, they can be movedto one or more work-flow stations using a container management device orlocator device, and/or transferred to a holding structure or rack, asdescribed elsewhere herein.

In one embodiment, as shown in FIGS. 1-3, 5A and 5B, the transportmechanism 204 is a conveyor belt 206 operable to transport (e.g.,convey) the containers 500 to an entrance location or port 110 andsubsequently through the entrance location or port 110 and into thedetection system 100. However, other means or mechanisms fortransporting the specimen containers 500 from the loading station orarea 202 to the entrance location or port 110 are envisioned, and mayinclude, but are not limited to, feed screws, timing belts havinggrooves or molded plates, and the like. In other embodiments, theprocess of automated loading of a specimen container 500 into thedetection system 100 may further comprise transferring the container toa holding structure or rack using a transfer mechanism 650 or moving thecontainer to one or more work-flow stations using a container locatordevice (see, e.g., FIG. 24, 400A), as described below.

As shown in FIGS. 1-3, 5A and 5B, the loading station or area 202 andtransport mechanism 204 comprise a conveyor belt 206. In accordance withthis embodiment, the user or technician can place one or more specimencontainers 500 at a specific location or area (i.e., the loading stationor area 202) of the conveyor belt 206 for automated loading of thecontainers 500 into the detection system 100. The conveyor belt 206 mayrun continuously, or may be activated by the physical presence of thecontainer 500 at the loading station or area 202. For example, a systemcontroller can be used to operate the conveyor belt 206 (i.e., turn iton or off) based on a signal (e.g., a light sensor) indicating thepresence, or absence, of one or more specimen containers at the loadingstation 202. Similarly, one or more sensors can be used at the entrancelocation or port 110 to indicate if a container is improperly loadedand/or has fallen over and may cause jamming The conveyor belt 206operates to move or transport the containers 500 from the loadingstation or area 202 (e.g., the left portion of the conveyor belt 206, asshown in FIG. 1) to the entrance location or port 110, therebyaccumulating one or more containers 500 at the entrance location or port110 to be loaded into the detection system 100. Typically, as shown inFIGS. 1-3 and 5A-5B, the loading station or area 202, transportmechanism 204 or conveyor belt 206, and entrance location or port 110are located outside, or on the housing 102 of the detection system 100.In one embodiment, the automated loading mechanism 200 is located on ashelf 180 located on top of the lower section 170 and adjacent to theupper section 160 of the system 100. Also, as shown, the transportmechanism or conveyor belt 206 typically operates in a horizontal plane,so as to maintain the specimen containers 500 in a vertical or up-rightorientation (i.e., such that the top portion 506 of the container 500 isup) for loading into the detection system 100 (see, e.g., FIGS. 1-3 and5A-5B). As shown in FIGS. 1-3, the transport mechanism or conveyor belt206 moves, for example, from left-to-right, or from the loading stationor area 202 towards the entrance location or port 110, to transport oneor more free standing containers 500 (see, e.g., FIG. 2, arrow 208).

In one embodiment, as shown, for example in FIGS. 1-3 and 10-11, theautomated loading mechanism 200 will further comprise one or more guiderails 210 located juxtaposed to one or both sides of the transportmechanism or conveyor belt 206. The one or more guide rails 210 functionto guide or direct the specimen containers 500 to the entrance locationor port 110 during operation of the transport mechanism or conveyor belt206. In one embodiment, the guide rails operate to funnel or guide thespecimen containers into a single file line at the back of the automatedloading mechanism 200, where they await their turn to be loaded, onecontainer at a time, into the detection system 100. In another designaspect, as shown for example in FIG. 22, the detection system 100 mayfurther comprise a locator device cover 460 that covers a locator device(described elsewhere herein) and encloses an interior locator devicechamber (not shown) therein. The locator device cover 460 may compriseone or more container guide rails 462 for guiding a specimen container500, as it is transported from the automated loading mechanism 200 tothe entrance location or port 110, and subsequently into the interiorchamber, thereby automatically loading the specimen contain into thesystem. In accordance with this embodiment, the interior locator devicechamber (not shown) is considered to be a part of the interior chamber,which is described elsewhere herein.

In still another embodiment, the automated loading mechanism 200 mayfurther comprise a means or device for reading or otherwise identifyingthe specimen containers 500 as the containers enter the detection system100. For example, the containers 500 may include a bar code label 508which can be read for container identification and tracking within thesystem. In accordance with this embodiment, the detection system 100will include one or more bar code readers (see, e.g., 410 in FIGS.14-15) at one or more locations within the system. For example, thedetection system 100 may include a bar code reader at the entrancelocation or port 110 to read, identify and log the individual containers500 into the detection system controller as they enter the system. Inanother embodiment, the entrance location or port 110 may also include ameans or device (e.g., a container rotator or rotating turntable, asdescribed elsewhere herein) for rotating the container within theentrance location or port 110 to enable reading of the bar code label508. In another possible embodiment, the transfer mechanism (see, e.g.,FIG. 5B, 650) may rotate the container 500 to enable reading of the barcode label 508. Once the bar code has been read, the transfer mechanismwill typically transfer the container 500 from the entrance location orport 110 to one of a plurality of receiving structures or wells 602 inone of a plurality of holding structures or racks 600.

In yet another embodiment, if the bar code 508 cannot be properly read,(e.g., the label is misread or a reading error occurs) the detectionsystem controller (not shown) can direct the container 500 to amisread/error location or port 120 for user access to the unreadable ormisread container 500. The user can re-load the container using theautomated loading mechanism 200 and/or at the user's discretion, mayoptionally manually load the container 500 and hand enter container 500information into the system controller (e.g., using the user interface150). In another embodiment, the detection system 100 may contain a highpriority (or STAT) loading location (not shown) for the loading of highpriority containers and/or for manual loading of containers where thelabel has been misread or a reading error has occurred.

Another design configuration of the automated loading mechanism is shownin FIG. 10. As shown in FIG. 10, the automated loading mechanism 200comprises a loading station or area 202, a first conveyor belt 206, andan entrance location or port 110. The conveyor belt 206 operates totransport the specimen containers 500 from the left edge of the system100 (i.e., the location of the loading station 202) to the entrancelocation or port 110. In this example, the movement is fromleft-to-right and is represented by arrow 220 in FIG. 10. The automatedloading mechanism 200 may further comprise a guide rail 210 and a secondconveyor belt 212, which operates around a set of gears or wheels 214,216. In accordance with this embodiment, the second conveyor belt 212 isorientated and operable in a vertical plane above the first horizontalconveyor belt 206, and can operate in a clockwise or counter-clockwisemanner (i.e., to move the belt from left-to-right or fromright-to-left). The clockwise or counter-clockwise operation of thesecond vertically orientated conveyor belt 212 can provide the specimencontainer 500 with a counter-clockwise or clockwise rotation,respectively, about a vertical axis of the container. Applicants havefound that providing a specimen container 500 with clockwise orcounter-clockwise rotation can prevent and/or reduce jamming or cloggingof the automated loading mechanism 200 as a plurality of specimencontainers 500 accumulate at the entrance location or port 110. Once thecontainers 500 have arrived at the entrance location or port 110 theycan be moved into the detection system 100.

In still another embodiment, the automated loading mechanism 200 mayalso contain a backer board (not shown) located in a horizontal planeunderneath the first conveyor belt 206. As one of skill in the art wouldappreciate, the conveyor belt 206 may have some give, flexibility, ormay otherwise be considered “springy”. This springy nature of theconveyor belt 206 may lead to instability of the specimen container 500as the container is transported across the conveyor belt 206 from theloading station or area 202 to the first port or entrance location 110and may result in specimen containers 500 tipping or falling over.Applicants have found that by including a rigid or semi-rigid backerboard underneath the conveyor belt 206, this problem can be reduceand/or eliminate altogether, thereby, reducing and/or preventing jammingor clogging of the loading mechanism 200 (e.g., with containers 500 thathave fallen over). In general, any known backer board material may beused. For example, the backer board can be a rigid or semi-rigid boardmade of plastic, wood, or metal.

Yet another configuration of the automated loading mechanism is shown inFIG. 11. As shown in FIG. 11, the automated loading mechanism 200 maycomprise a loading station or area 202, a conveyor belt 206, and anentrance location or port 110. Also as shown, the conveyor belt 206 canoperate to transport the specimen containers 500 from the front edge ofthe system 100 (i.e., the loading station 202) to the entrance locationor port 110. In this example, the movement of the loading mechanism 200is from front-to-back (i.e., from the front edge of the instrument tothe loading port 110) and is represented by arrow 240 in FIG. 11. Asshown, the automated loading mechanism 200 may further comprise one ormore guide rails 210 to guide the one or more specimen containers 500 tothe entrance location or port 110, as they are transported by theconveyor belt 206.

Optionally, as shown in FIG. 11, the automated loading mechanism 200, inaccordance with this embodiment, may include a second transportmechanism 230. In one embodiment, the second transport mechanism 230 maycomprise a second conveyor belt 232 located in, and operable in, avertical plan above the first conveyor belt 206. As shown, the secondtransport mechanism 230 may further comprise a plurality of paddles orplates 236 attached to the second conveyor belt 232. In accordance withthis embodiment, the first conveyor belt 206 operates to move ortransport one or more specimen containers 500 from the loading stationor area 202 to the second transport mechanism 230, where the containers500 are individually moved or transported into a well or space 234between the paddles or plates 236. The second conveyor belt 232 operatesaround a set of gears or drive wheels (not shown), and runs or moves,for example, from left-to-right across the back edge of the automatedloading mechanism 200, thereby transporting the containers 500 fromleft-to-right along the back of the loading mechanism 200 and to theentrance location or port 110 (see, e.g., arrow 250). Once thecontainers 500 have arrived at the entrance location or port 110 theycan be moved into the detection system 100.

In yet another embodiment, the automated loading mechanism 200 can beenclosed or encased in a protective housing or casing 260, as shown forexample in FIG. 12. In accordance with this embodiment, the automatedloading mechanism 200, or one or more components thereof (i.e., one ormore of the loading area, transport means (e.g., conveyor belt 206)and/or entrance location or port (not shown)), can be housed or encasedin a protective housing or casing 260. The protective housing or casing260 will have an opening 262 providing access to, and for loadingspecimen container 500 into/onto the automated loading mechanism 200housed therein. Optionally, the protective housing or casing 260 canfurther include a cover means 264 that can be closed or shut to protectthe automated loading mechanism 200, and/or containers 500, containedtherein. The cover can be a closable lid 266, as shown, or otherstructure or means for closing the housing or casing 260. For example,in another embodiment, the cover 264 can be a lightweight curtain (notshown) that can be pulled shut over the opening 262. The protectivehousing or casing 260 may also provide a priority container loading port270 for the loading or high priority containers (i.e., STAT container)and/or misread containers. In one embodiment, a container 500 can bemanually loaded into the priority port 270.

Another embodiment of an automated loading mechanism is shown in FIGS.13-15. Like the previously described automated loading mechanism, theautomated loading mechanism 300 shown in FIGS. 13-15, comprises acontainer loading station or area 302, a transport mechanism 304 and acontainer entrance location 306, for the fully automated loading of oneor more specimen containers 500 into the detection system 100.

The container loading area 302 is in an easily accessible location onthe detection system 100 to allow a user to easily place one or morespecimen containers 500 therein, as shown for example in FIG. 17. Inaccordance with this embodiment, the specimen containers 500 are loadedin a horizontal orientation, such that they are lying on their side, asshown for example in FIG. 13. Once at the container loading area 302,the specimen containers 500 can be transported by a transport mechanism304 from the container loading area 302 to an entrance location 306,from where the containers 500 will enter the detection system 100, asdescribed in more detail herein. Surprisingly, regardless of thespecimen container 500 orientation in the loading area 302 (i.e.,regardless of whether the top portion 506 of the container 500 is facingthe detection system 100 or facing away from the detection system 100(as shown, e.g., in FIG. 14)), the automated loading mechanism 300 ofthis embodiment is capable of loading the specimen containers 500 intothe detection system 100.

In one embodiment, the container loading station or area 302 comprises aloading reservoir 303 that is capable of holding one or more specimencontainers 500, as shown for example in FIG. 13. The loading reservoir303 can be designed to hold from 1 to 100 specimen containers, from 1 to80 specimen containers, or from 1 to 50 specimen containers. In otherdesign concepts, the loading reservoir may hold 100 or more specimencontainers 500. The automated loading mechanism 300 of this embodimentmay further comprise a lid or cover (not shown), which the user ortechnician can optionally close to cover the loading reservoir 303 andloading area 302. Various designs are possible and contemplated for thelid or cover.

As show in FIGS. 13-14, the loading reservoir 303 contains a transportmechanism 304, for example, a sloped ramp that slopes downwards towardsan entrance location 306 so as to transport the specimen containers 500from the loading area 302 to the entrance location 306. In accordancewith this embodiment, the sloped ramp will allow the specimen containersto roll or slide down the ramp to the entrance location 306. Although, asloped ramp is exemplified in the figures other designs are possible andcontemplated for the transport means or mechanism 304 for transportingthe specimen containers to the entrance location 306. For example, inone alternative design concept the transport mechanism 304 may comprisea conveyor belt (not shown). In accordance with this design concept theconveyor belt can be designed to hold one or more specimen containersand may optionally be designed such that the conveyor belt slopesdownward towards the entrance location 306.

Once at the entrance location 306, a drum or drum-like loading device308 will be used for loading the specimen containers 500 into thedetection system 100. As shown, the drum-like loading device 308 has oneor more horizontally orientated slots 310 for holding one or morespecimen containers therein. Each individual slot 310 is capable ofholding a single specimen container 500. In one embodiment, thedrum-like loading device 308 has a plurality of slots, for example, from1 to 10 slots, from 1 to 8 slots, from 1 to 6 slots, from 1 to 5 slots,from 1 to 4 slots, or from 1 to 3 slots for holding specimen containers500 therein. In another embodiment, the drum-like loading device 308 canbe designed to have a single slot capable of holding a single specimencontainer 500 therein.

The drum-like loading device 308 is capable of rotating (either in aclock-wise direction, or counter-clock wise direction) about ahorizontal axis, and is capable of picking-up and loading individualspecimen container 500 into the detection system 100. In operation, therotation of the drum or drum-like loading device 308 picks up ahorizontally orientated specimen container 500 in one of a plurality ofhorizontally orientated slots 310, and moves the container 500, byrotation of the drum or drum-like loading device to a tumbler device 330(see, e.g., FIG. 16). Any known means in the art can be used forrotation of the drum or drum-like loading device 308. For example, thesystem may employ the use of a motor (not shown) and drive belt 316 forrotation of the drum-like loading device 308.

In another embodiment, as shown in FIG. 13, the automated loadingmechanism 300 of this embodiment may further comprise a single containerloading port 312. In operation, a user or technician can place a singlespecimen container into the single container loading port 312 for quick,or immediate loading, for example of a STAT specimen container. Onceplaced in the single container loading port 312, the container will dropor fall via gravity onto a second transport mechanism 314, for example,a sloped ramp that slopes downward toward the drum-like loading device308 for quick or immediate automated loading of the specimen containerinto the detection system 100.

As shown in FIGS. 13-16, the drum or drum-like loading device 308rotates in a vertical plane (i.e., around or about a horizontal axis) tomove the specimen container 500 from the entrance location 306 to atumbler device 330. The tumbler device comprises an open slot at the topof a vertically orientated chute 332. Once moved to the tumbler device330, the specimen containers are up-righted (i.e., the specimencontainers are re-positioned from a horizontal container orientation toan up-right vertical container orientation) by a cam mechanism andvertically orientated chute 332. In operation, the cam mechanism (notshown) is capable of sensing the top and/or bottom of the specimencontainer, and pushing the specimen container 500 in a horizontaldirection from the base of the specimen container, thereby allowing thebase to drop or fall through the opening of a vertically orientatedchute 332. Accordingly, the tumbler device 330 operates to allow thecontainer 500 to drop (via gravity) bottom first through the verticalchute 332 and into a first locator well of a container locator device400 (described elsewhere herein), thereby re-orientating the container500 in a vertical, up-right orientation.

As shown for example in FIG. 16, the tumbler device 330 has two taperedledges 334, one on each side of the drum, each being narrow at a frontedge and thicker at a back edge. The ledges 334 are aligned so that thecap portion 502 of the container 500 will be caught or held by the ledge(i.e., the cap will move over the top side of the ledge such that thecap will rest on the top of ledge 334) as the drum rotates. The ledge334 only holds the cap portion 502 of the container 500 in placebriefly, as the bottom of the container falls through the vertical chute332. Furthermore, the bottom or base 506 of the container will not becaught or held by the ledge. Instead, the tapered ledge 334 will act topush or slide the bottom or base 506 of the container 500 in ahorizontal direction, from the bottom 506 of the container 500 towardsthe top or cap portion 502 of the container (see FIG. 4), as the drum ordrum-like loading device 308 rotates. This action helps to ensure thatthe cap end 502 of the container is held by the top edge of the ledge334, thereby allowing the bottom 506 of the container 500 to fall freelythrough the vertical chute 332 and into the container locator device400. By having a ledge 334 on each side of the drum or drum-like loadingdevice 308, container 500 orientation in the rotating drum in notessential. The container 500 will be up-right by the tumbler device 330regardless of whether the cap end 502 of the container is on the rightor left side (see, e.g., FIG. 16) of the drum-like loading device 308,as the corresponding ledges 334 will function to hold the cap or top 502of the container as the bottom 506 falls through the vertical chute 332.In another embodiment, the vertical cute 332 may further comprise anarrower section 333 that helps direct the falling container 500 intothe container locating device 400. In operation, as the drum ordrum-like loading device 308 rotates over the open slot at the top ofthe vertically orientated chute 332, the cap or top portion 502 of thecontainer 500 is held at the outer edge of the drum by one or moreledges 334 (see, e.g., FIG. 16). The ledges 334 hold the cap or topportion 502 of the container 500 in place while allowing the bottom 506of the container to swing or fall freely out of the drum or drum-likeloading device 308 and into the vertically orientated chute 332, therebyup-righting or vertically orientating the container 500 as it drops orfalls via gravity through the vertically orientated chute 332 bottomfirst, as previously described.

Container Management Means or Locator Device

As shown, for example in FIGS. 13-15, 18, and 25A-25C the detectionsystem 100 may further comprise a container management device or locatordevice 400. The container management device or locator device 400 can beused to manage, move or otherwise locate a container 500, once insidethe housing 102 of the detection system 100, among various work-flowstations 404. In one embodiment, the container management device orlocator device 400 can be used in combination with the automated loadingmechanism 300 shown in FIGS. 13-15, as shown. In another embodiment, thecontainer management device or locator device 400 can be used incombination with the automated loading mechanism 200 shown, for example,in FIG. 18. The container management device or locator device 400 inFIGS. 13-15 and 18 is shown schematically and the parts not to scale.

The container management device or locator device 400 comprises arotatable wheel-like device or rotatable disk that contains one or morelocator wells 402, for example 1 to 10 locator wells, 1 to 8 locatorwells, 1 to 5 locator wells, 1 to 4 locator wells, or 1 to 3 locatorwells 402. In one embodiment, the locator device comprises opposableparallel plates or discs (see, e.g., FIGS. 25A-25C). Each individuallocator well 402 is capable of holding a single specimen container 500.In operation, the locator device 400 rotates (either clock-wise orcounter clock-wise) in a horizontal plane (and around or about avertical axis) to move an individual container 500 to or among variouswork-flow stations 404 (i.e., from station-to-station). In oneembodiment, the work-flow station 404 is operable to obtain one or moremeasurements or readings of the specimen container, thereby providinginformation about the container, such as, container lot number,container expiration date, patient information, sample type, fill level,etc. In another embodiment, the one or more work-flow stations 404 maycomprise one or more container management stations, such as, a containerpick-up station or a container transfer station. For example, thelocator device 400 is capable of moving an individual specimen container500 to one or more work-flow stations 404, such as: (1) a bar codereading station; (2) a container scanning stations; (3) a containerimaging station; (4) a container weighing station; (4) container pick-upstation; and/or (5) a container transfer station. In another embodiment,one or more of these measurements and/or readings can occur at the samestation. For example, container weight, scanning, imaging and/or pick-upmay occur at a single station location. In yet another embodiment, thedetection system may contain a separate pick-up station. A container canbe picked-up by a transfer mechanism (as described herein) at thepick-up location, and transferred to other locations (e.g., to a holdingstructure and/or agitation assembly) within the detection system 100. Instill another embodiment, the detection system 100 may contain atransfer station for the transfer of a specimen container 500 to anotherinstrument, e.g., a second automated detection instrument. In accordancewith this embodiment, the transfer station may communicate with a systemtransfer device 440. For example, as shown, the system transfer device440 may be a conveyor belt that allows the specimen container to betransferred to another location within the detection system 100, or inanother embodiment, to another instrument (e.g., a second detectionsystem (e.g., as shown in FIG. 24)). As shown in FIG. 14-15, the locatordevice 400 comprises: (1) an entrance station 412; (2) a bar codereading and/or scanning station 414; (3) a container weighing station416; (4) a container pick-up station 418; and (5) a system transferstation 420 for transfer of the container to another instrument. Thelocator device may further comprise a rotatable turntable device 406,for rotating a container to facilitate bar code reading and/or containerscanning, and/or a scale or weighing device 408, for weighing acontainer.

As previously described, in operation, the container management deviceor locator device 400, operates to move or otherwise locate a givenspecimen container 500 to a given work-flow station 404. In oneembodiment, these work-flow stations 404 are included within the housing102 of the detection system 100. For example, as shown in FIGS. 13-15and 18, an automated loading mechanism can deposit or place a specimencontainer 500 into a locator well 402, as described elsewhere herein.The container management means or locating device 400 can then rotate tomove or locate the specimen container among various work-flow stationswithin the system, such as for example, a bar code reading station, acontainer scanning stations, a container imaging station, a containerweighing station, container pick-up station, and/or a container transferstation.

Transfer Means or Mechanism

As shown, for example in FIGS. 5-9B and 17-21, the automated detectionsystem 100 may further comprise an automated transfer means or mechanismoperable for the transfer of a specimen container 500, and/or forcontainer management, within the system. As already described, theentrance location or port 110 receives containers from, for example, aconveyor system 206 shown best in FIGS. 1-3. As the containersaccumulate in the entrance location or port 110, the containers aremoved within the detection system 100 whereby a transfer mechanism(e.g., a robotic transfer arm with a container gripping means) canpick-up, or otherwise receive, an individual specimen container 500 andtransfer and place that container into a holding structure or rack 600within the detection system 100, as described in more detail herein. Asknown in the art, the transfer mechanism may use a vision system (e.g.,camera), pre-programmed dimensional coordinates and/or precision motioncontrolling to transfer a specimen container to, and load the specimencontainer into, the holding structure or rack 600.

As shown in FIGS. 1-3 and 13-15, specimen containers 500 are loadedinto, and/or transported within, the detection system 100 using anautomated loading mechanism 200 (FIGS. 1-3) or 300 (FIGS. 13-15). Asshown, the containers 500 are typically loaded into the detection system100 in a vertical orientation (i.e., such that the top or cap portion502 of the container 500 is up-right). In accordance with oneembodiment, the containers 500 are placed or held in a plurality ofholding structures or racks 600, and optionally agitated to enhancemicroorganism growth therein. As shown for example in FIGS. 5A and 5B,the receiving structures or wells 602 of the holding structures or racks600 can be orientated in a horizontal axis. Accordingly, in accordancewith this embodiment, an automated transfer mechanism (see, e.g., FIG.5B, 650) must re-orientate the container 500, from a verticalorientation to a horizontal orientation, during the transfer of thecontainer 500 from the automated loading mechanism 200, 300 to thereceiving structures or wells 602.

In operation, the automated transfer mechanism (e.g., FIG. 5B, 650 orFIG. 20, 700) can operate to transfer or otherwise move, or relocate, aspecimen container 500 within the interior chamber 620 of the detectionsystem 100. For example, in one embodiment, the transfer mechanism cantransfer a specimen container 500 from an entrance location or port 110to one of a plurality of holding structures or racks 600. In anotherembodiment, the transfer mechanism can pick-up a specimen container 500from a well 402 of the container locator device 400 and transfer thecontainer to a holding structure or well 602 of the holding structure orrack 600. The transfer mechanism can operate to place the container 500in one of a plurality of container receiving structures or wells 602that are located in one of a plurality of holding structures or racks600. In another embodiment, the transfer mechanism can operate to removeor unload “positive” and “negative” containers from the holdingstructures or racks 600. This automated unloading mechanism can operateto ensure that once a “positive” or “negative” reading has been made foreach specimen container 500, the container 500 is removed from thecontainer receiving structures or well 602, making room for anothercontainer to be loaded into the detection system 100, thereby increasingsystem through-put.

In one embodiment, the transfer mechanism can be a robotic transfer arm.In general, any type of robotic transfer arm known in the art can beused. For example, the robotic transfer arm can be a multi-axis roboticarm (for example, a 2-, 3-, 4-, 5-, or 6-axis robotic arm). The robotictransfer arm can operate to pick-up and transfer a specimen container500 (e.g., a blood culture bottle) from an entrance location or port 110to one of a plurality of container receiving structures or wells 602located in one of a plurality of holding structures or racks 600(optionally having an agitation assembly). Furthermore, to facilitatethe necessary movements of the transfer mechanism or robotic transferarm, the interior chamber 620 of the detection system 100, may includesone or more supports for the robotic transfer arm. For example, one ormore vertical supports and/or one or more horizontal supports may beprovided. The transfer mechanism or robotic transfer arm will slide upand down and across the supports as necessary to access any of thereceiving structures or wells 602 of the holding structures or racks600. As previously described, the robotic transfer arm can operate tochange the orientation of a specimen container from a verticalorientation (i.e., up-right orientation such that the top 502 of thecontainer 500 is up) to a horizontal orientation (i.e., such that thecontainer 500 is laying on it's side), for example, to facilitate incontainer transfer from a loading station or location, and placementwithin a holding structure and/or agitation assembly.

In one embodiment, the robotic transfer arm is a 2-, or 3-axis roboticarm and will be capable of transferring the container 500 in one or morehorizontal axes (for example, the x- and/or z-axes) and optionally avertical axis (y-axis) to a specific location, such as the containerreceiving structures or wells 602 described herein. In accordance withthis embodiment, a 2-axis robotic arm will allow movement in 2-axes (forexample, the x-, and z-axes), whereas a 3-axis robotic arm will allowmovement in 3-axes (for example, the x-, y-, and z-axes).

In another embodiment, the 2-, or 3-axis, robotic arm may further employone or more rotational movements, capable of transferring or moving thespecimen container 500 rotationally about one or more axes. Thisrotational movement may allow the robotic transfer arm to transfer aspecimen container 500 from a vertical loading orientation to ahorizontal orientation. For example, the robotic transfer arm may employa rotational movement to move the specimen container rotationally aboutor around a horizontal axis. This type of robotic transfer arm would bedefined as a 3-, or 4- axis robotic arm. For example, a robotic arm thatallows movement in one horizontal axis (the x-axis), one vertical axis(e.g., the y-axis) and one rotational axis would be considered a 3-axisrobotic arm. Whereas, a robotic arm that allows movement in twohorizontal axes (e.g., the x-, and z-, axes), a vertical axis (they-axis) and one rotational axis would be considered a 4-axis roboticarm. Similarly, a robotic arm that allows movement in a singlehorizontal axis (e.g., the x-axis), a vertical axis (the y-axis) and tworotational axes would also be considered a 4-axis robotic arm. In yetanother embodiment, the robotic transfer arm 700 can be a 4-, 5-, or6-axis robotic arm, thereby allowing movement in the x-, y-, and z-axes,as well as rotational movement about, or around, one-axis (i.e., a5-axis robot), two axes (i.e., a 5-axis robotic arm), or all threehorizontal (x-, and z-axes) and vertical axes (y-axes) (i.e., a 6-axisrobotic arm).

In yet another embodiment, the robotic transfer arm may include one ormore devices for obtaining measurements, scans and/or readings of aspecimen container 500. For example, the robotic transfer arm mayinclude one or more video cameras, sensors, scanners, and/or bar codereaders. In accordance with this embodiment, the video camera, sensor,scanner and/or bar code reader may aid in container location, reading ofcontainer labels (e.g., bar codes), container scanning, remote fieldservicing of the system, and/or detecting for any possible containerleaks within the system. In yet another design possibility, the robotictransfer arm may include a UV light source to aid in automateddecontamination, if necessary.

One design possibility of the transfer mechanism is shown in FIGS. 6-8C.As shown in FIG. 6, the transfer mechanism comprises a robotic transferarm 650, which comprises an upper horizontal support rail 652A, a lowerhorizontal support rail 652B, a single vertical support rail 654 and arobotic head 656 that will includes a gripping mechanism (not shown) forpicking-up, gripping or otherwise holding a specimen container 500. Thetransfer mechanism shown in FIGS. 6-8C is shown schematically and theparts not to scale, for example, the horizontal supports 652A, 652B,vertical support and robotic head 656 shown are not to scale. As one ofskill in the art would readily appreciate, the horizontal supports 652A,652B, and vertical support can be increased or decreased in length asneeded. As shown, the robotic head 656 is supported by, coupled to,and/or attached to the vertical support rail 654, which in turn issupported by the horizontal support rails 652A and 652B. Also as shownin FIG. 6, the transfer mechanism may comprise one or more mountingsupports 696 that can be used to mount the transfer mechanism in thedetection system.

In operation, the vertical support rail 654 can be moved along thehorizontal support rails 652A and 652B, thereby moving the verticalsupport rail 654 and the robotic head 656 along a horizontal axis (e.g.,the x-axis). In general, any known means in the art can be used to movethe vertical support rail 654 along the horizontal support rails 652Aand 652B. As shown in FIG. 6, the upper and lower support rails 652A and652B, can comprise upper and lower threaded shafts (not shown) operableto drive upper and lower horizontal slide blocks 659A and 659B,respectively. Also, as shown in FIG. 6, the upper and lower shafts 652Aand 652B can include hollow, elongate reinforcing sleeves 653A, 653Bthat extends the length of the upper and lower support rails 652A, 652B,and thereby surrounds the upper and lower threaded screws (see, e.g.,U.S. Pat. No. 6,467,362). The sleeves 653A, 653B will each furthercomprise a slot (see, e.g., 653C) in the sleeve 653A, 653B that extendsthe length of the upper and lower support rails 652A, 652B. Threadedtongues (not shown) are provided that extend through the slot (see,e.g., 653C) and have threads engageable with the threaded shafts (notshown) which are encased in the reinforcing sleeves 653A, 653B. As thethreaded shafts (not shown) of the upper and lower support rails 652A,652B are turned by a first motor 657, the threaded tongues (not shown)moves horizontal slide blocks 659A, 659B along the longitudinal lengthof the upper and lower support rails 652A, 652B, thereby moving therobotic head 656 along a horizontal axis (e.g., the x-axis) (again, see,e.g., U.S. Pat. No. 6,467,362). A first motor 657 can operate to turnthe upper and lower threaded shafts (not shown) and thereby drive upperand lower horizontal slide blocks 659A and 659B (each having internalthreads that engage the threaded shafts, respectively) in a horizontaldirection along the upper and lower threaded shafts. In one designpossibility, the first motor 657 can be used to turn both the upper andlower threaded shafts by including a drive belt 660 and set of pulleys662 to turn one of the threaded shafts (e.g., the lower threaded shaft)in parallel with the first threaded shaft, as the first threaded shaftis turned by the motor 657.

As shown in FIG. 6, the vertical support rail 654 may further comprise avertical threaded drive shaft (not shown) operable to drive a verticalslide block 655 and thereby move the robotic head 656 along a verticalaxis (e.g., the y-axis). In operation, a second motor 658 can operate toturn a vertical threaded shaft (not shown) and thereby drive verticalslide block 655 in a vertical direction along the vertical threadedshaft. In another embodiment, as shown in FIGS. 6-7B, and as describedhereinabove, the vertical threaded shaft may further comprise a hollow,elongate reinforcing sleeve 654A that extends the length of the verticalsupport rail 654, and thereby surrounds the vertical threaded shaft (notshown). The sleeve 654A will further comprise a slot 654B that extendsthe length of the vertical support rail 654. A threaded tongue (notshown) is provided that extends through the slot (not shown) and hasthreads engageable with the threaded shaft (not shown). As the threadedshaft (not shown) is turned by motor 658, the threaded tongue (notshown) moves a vertical slide block 655, thereby moving the robotic head656 along a vertical axis (e.g., the y-axis) (again, see, e.g., U.S.Pat. No. 6,467,362). The vertical slide block 655 may be directlyattached to the robotic head 656, or as shown in FIG. 6, may be attachedto a first rotational mechanism 664. The vertical slide block 655 hasinternal threads (not shown) that engage the threaded vertical shaft andoperated to drive the vertical slide block, and thus the robotic head656, in a vertical direction, along the threaded vertical shaft.

The transfer mechanism 650 may further comprise one or more rotationalmechanisms operable to provide rotational movement about or around oneor more axes. For example, as shown in FIG. 6, the robotic head maycomprise a first rotational mechanism 664 for providing rotationalmovement about or around the y-axis and a second rotational mechanism665 for providing rotational movement about or around the x-axis. Thefirst rotational mechanism 664 comprises a first rotational plate 667that can be attached to the robotic head 656. The first rotationalmechanism 664 further comprises a first rotational motor 668, a firstpinion gear 670 and a first opposable ring gear 672, which operate torotate the first rotational plate 667, and thus the robotic head 656,about a vertical axis (e.g., about the y-axis). In one embodiment, as iswell known in the art, the first pinion gear 670 and first ring gear 672may be provided with gripping teeth (not shown) or other grippingfeature (not shown). The first rotational plate 667 may be directlyattached to the robotic head 656, or as shown in FIG. 6, may be attachedto a second rotational mechanism 665. Also as shown in FIG. 6, the firstrotational plate 667 may comprise a bent plate to facilitate attachmentto the second rotational mechanism 665. The second rotational mechanism665, like the first rotational mechanism 664, comprises a secondrotational plate 674. As shown in FIG. 6, the second rotational plate674 is attached to the robotic head 656. The second rotational mechanism665 further comprises a second rotational motor 678, a second piniongear 680 and a second opposable ring gear 682, which operate to rotatethe second rotational plate 674, and thus the robotic head 656, about ahorizontal axis (e.g., the x-axis). In one embodiment, as is well knownin the art, the second pinion gear 680 and second ring gear 682 may beprovided with gripping teeth (not shown) or other gripping feature (notshown).

The robotic head 656, best shown in FIG. 7B, comprises a housing 684enclosing a holding chamber 685 for holding a single specimen container500 therein. The robotic head further comprises a gripping mechanism 686and a drive mechanism 688 to move the gripping mechanism 686, andthereby a single specimen container 500, into and out of the housing 684and holding chamber 685. The gripper mechanism 686, as shown in 7B, maycomprise a spring clip 687 operable to snap over the lip of a specimencontainer 500. After transferring the specimen container 500 to aholding structure 600, as described elsewhere herein, the robotic head656, and thus the gripping mechanism 686, can be raised or loweredrelative to the holding structure 600 to release the specimen container500. The drive mechanism 688 further comprises a motor 690, a guide rail692, a threaded gripper shaft 694 and a gripper drive block 696, asshown in FIG. 7B. In operation, the motor 690 turns the threadedgripping shaft 694, thereby moving the gripping drive block 696, andthus the gripping mechanism 686 along the guide rail 692.

Another design possibility of the transfer mechanism is shown in FIGS.9A-9B. As shown in FIGS. 9A-9B an automated transfer mechanism 820 isincorporated into the detection system 100 shown in FIGS. 9A-9B in orderto grasp or pick-up a container 500 from the entrance location or port110, and move or transfer a container 500 to a give receiving structureor well 802, of an upper or lower drum holding structure 800 (describedelsewhere herein). The automated transfer mechanism 820 in thisembodiment is also operable to move a negative container 500 to a wastelocation and subsequently dropping or otherwise depositing the container500 into a waste bin 146, or operable to move a positive container to apositive container location (see, e.g., 130 in FIG. 1). To provide suchmovement, the transfer mechanism 820 includes a robotic head 824 whichmay include a gripping mechanism 826 for picking-up and holding acontainer 500, and a rotatable support rod 828 that extends across theinterior chamber 850 of the system 100. As shown, the robotic head 824is supported by, coupled to, and/or attached to the rotatable supportrod 828. In general, the gripping mechanism can be any known grippingmechanism in the art. In one embodiment, the gripping mechanism may bethe gripping mechanism and drive mechanism described hereinabove inconjunction with FIGS. 6-8C. The robotic head 824 is moveable to anyposition along the rotatable support rod 828. In operation, the supportrod 828 can be rotated about its longitudinal axis, so as to orient therobotic head 824 towards either the upper or lower cylinder or drumholding structures 800A, 800B.

In one embodiment, the robotic head 820 is operable to pick-up acontainer 500 from the entrance location or port 110 and load thecontainer 500 head-first (i.e., top portion 502 first) into thereceiving structures or wells 802 of the drum holding structures 800A,800B. This orientation exposes the bottom or base 506 of the container500 to a detection unit 810 which can read the sensor 514 located at thebottom of the container 500 to detect microbial or microorganism growthwithin the container.

Yet another design possibility for the transfer mechanism is shown inFIGS. 17-21B. As shown in FIGS. 17-21B, the robotic transfer arm 700will include one or more horizontal support structures 702, one or morevertical support structures 704, and a robotic head 710 that willinclude one or more features or devices (e.g., a gripping mechanism) topick-up, grip and/or hold a specimen container 500. The robotic head 710can be supported by, coupled to, and/or attached to one of thehorizontal supports and/or vertical supports. For example, in oneembodiment, as shown in FIGS. 17-21B, the robotic transfer arm 700comprises a lower horizontal support structure 702B and a singlevertical support structure 704. Although, not shown, as one of skill inthe art would appreciate an upper horizontal support structure (notshown), or other similar means can be used to further support or guidethe vertical support structure. In general, any known means in the artcan be used to move the robotic head 710 up and down the verticalsupport rail 704 (as represented by arrow 726 (see FIG. 18)), and movethe vertical support rail 704 back-and-forth along the horizontalsupport structure(s) 702B (as represented by arrow 736 (see FIG. 20)).For example, as shown in FIG. 20, the robotic transfer arm 700 mayfurther comprises a vertical drive motor 720 and vertical drive belt 722that will operate to transfer or move the robotic head 710 up and down(arrow 726) the vertical support rail 704 to transfer or move acontainer 500 along (i.e., up and down) a vertical axis (i.e., they-axis). The vertical support structure 704 may further comprise avertical guide rail 728 and a robotic head support block 708, as shownin FIG. 20. Accordingly, the vertical support structure 704, verticalguide rail 728, vertical drive motor 720 and vertical drive belt 722allow the robotic transfer arm 700 to move or transfer the robotic headsupport block 708, and thus, the robotic head 710 and a specimencontainer 500 along the y-axis. Likewise, also as shown in FIG. 20, therobotic transfer arm 700 may further comprise a first horizontal drivemotor 730, first horizontal drive belt 732 and horizontal guide rail 738that will operate to move the vertical support structure 704back-and-forth (i.e., from left-to-right and/or from right-to-left)along the horizontal guide rail 738, and thus, along a first horizontalaxis (i.e., the x-axis) within the housing 102 of the detection system100 (see arrow 736)). Accordingly, the horizontal support structure(s)702B, first horizontal drive motor 730, first horizontal drive belt 732and horizontal guide rail 738 allow the robotic transfer arm 700 to moveor transfer a specimen container 500 along the x-axis. Applicants havefound that by including a vertical support that is movable along ahorizontal axis allows for an increased capacity within the detectionsystem, as the robotic transfer arm is movable over an increased areawithin the instrument. Furthermore, Applicants believe a robotictransfer arm having a movable vertical support may provide a morereliable robot transfer arm.

As shown best in FIG. 17-21B, the automated transfer mechanism orrobotic transfer arm 700 may further comprise a linear or horizontalslide 706 and pivot plate 750. As shown, for example in FIGS. 17-20, thelinear or horizontal slide 706 supports the robotic head 710 and grippermechanism 712. The linear or horizontal slide 706 and robotic head 710may be supported by, coupled to, and/or attached to, a robotic headsupport block 708 and vertical guide rail 728 (previously described). Inaccordance with this embodiment, the linear or horizontal slide 706 canbe moved up and down (see FIG. 18, arrow 726) along a vertical axis(i.e., the y-axis), via the a robotic head support block 708 andvertical guide rail 728, to move or transfer the robotic head 710 and/orspecimen container 500 up and down within the housing 102 of thedetection system 100 (i.e., along the vertical axis (y-axis)). As shownin FIGS. 21A-21B, the linear or horizontal slide 706 may furthercomprises a pivot plate 750 comprising a pivot plate guide rail 752, apivot slot 754 and pivot slot cam follower 756 operable to allow therobotic head 710 to slide or moved along the linear or horizontal slide706, from front-to-back or from back-to-front (see FIG. 18, arrow 746),to transfer or move a container 500 along a second horizontal axis(i.e., the z-axis). In accordance with this embodiment, a secondhorizontal drive motor or horizontal slide motor 760 and a slide belt(not shown) can be used to move the robotic head 710 along the z-axis.Accordingly, the linear or horizontal slide 706, the horizontal slidemotor and slide belt, allows the robotic head 710 to move or transfer aspecimen container 500 along the z-axis. As known in the art, one ormore sensors (see, e.g., 764 in FIG. 21A) can be used to indicate theposition of the robotic head 710 on the linear or horizontal slide 706.

As shown in FIGS. 21A-21B, as the robotic head 710 is moved along thelinear or horizontal slide 706, pivot plate 750 and pivot plate guiderail 752, the pivot slot 754 and pivot slot cam follower 756 rotate thepivot carriage 758 about or around a horizontal axis (i.e., the z-axis),and thus, rotates the robotic head 710 from a horizontal orientation (asshown in FIG. 21A) to a vertical orientation (as shown in FIG. 21B), orvice versa. As described elsewhere herein, the transfer of a container500 from a vertical entry orientation to a horizontal orientation may benecessary for depositing or placing the container in a horizontallyorientated receiving structure or well 602 of the holding structure orrack 600. Accordingly, the pivot plate 750, pivot slot 754 and pivotcarriage 758 allow the robotic head 710 to re-orientate a specimencontainer 500 from a vertical orientation, as loaded (see, e.g., FIG.18) to a horizontal orientation (as seen, e.g., in FIG. 21A), therebyallowing a specimen container 500 to be transferred from an automatedloading mechanism (see, e.g., 200 in FIG. 18) to a well in a holdingstructure (e.g., 602 and 600 in FIG. 18). As shown in FIG. 20 theautomated transfer mechanism may also comprise one or more cablemanagement chains 782, for cable management within the detection system100, and a circuit board 784 for controlling the robotic transfermechanism. In yet another embodiment, the robotic transfer arm 700 mayfurther comprise a break mechanism 786 that can operate to break thevertical drive belt 722, thereby preventing if from falling to thebottom of the instrument (e.g., due to a power outage).

The robotic transfer arm 700 may further comprise a gripping mechanism712 to pick-up, grip or otherwise hold a specimen container 500. Asshown, for example in FIGS. 21A and 21B, the gripping mechanism maycomprise two or more gripping fingers 714. Furthermore, the grippingmechanism 712 may further comprise a linear actuator 716 and a linearactuator motor 718 which can operate to move the linear actuator to openand close the gripper fingers 714. In operation, as is well known in theart, the actuator motor 718 can be used to move the linear actuator 716of the gripper mechanism 712 thereby moving the gripper fingers 714. Forexample, the linear actuator can be moved in a first direction (e.g.,toward the motor) to close the fingers and grip the container 500.Conversely, the linear actuator can be moved in a second direction(e.g., away from the motor) to open the gripper fingers and release thecontainer 500. Applicants have unexpectedly found that the use of one ormore gripping fingers 714 allows the gripping mechanism 712 toaccommodate (i.e., pick-up and/or hold) a large variety of differentspecimen containers 500. Moreover, Applicants have found that by usinggripper fingers 714 that extend from about one-quarter (¼) to aboutone-half (½) the length of the specimen container 500, the gripperfingers will accommodate (i.e., pick-up and/or hold) a number of wellknown containers (e.g., long neck blood culture bottles) in the art.

As described further herein, the automated transfer mechanism or robotictransfer arm 700 can be placed under the control of a system controller(not shown) and programmed for specimen container 500 management (e.g.,pick-up, transfer, placement and/or container removal) within thedetection system 100.

In yet another embodiment, as discussed further hereinbelow, thetransfer mechanism 700 can be used for automated unloading of “positive”and “negative” specimen containers 500.

Holding Means or Structure with Optional Agitation Means

The holding means or structure of the detection system 100 can take avariety of physical configurations for handling a plurality ofindividual specimen containers 500 so that a large number of containers(e.g., 200 or 400 containers, depending on the specific holdingstructures used) can be processed simultaneously. The holding means orstructure can be used for storage, agitation and/or incubation of thespecimen containers 500. One possible configuration is shown in FIGS.5A-5B, and another possible configuration is shown in FIGS. 9A and 9B.These configurations are provided by way of illustration and notlimitation. As one of skill in the art will appreciate, other designsare possible and contemplated.

As shown in FIGS. 5A-5B and FIGS. 17-20, one possible configuration usesa plurality of vertically stacked container holding structures or racks600 each having a multitude of specimen container receiving structuresor wells 602 each for holding individual specimen containers 500. Inaccordance with this embodiment, two or more vertically stacked holdingstructures or racks 600 can be used. For example, from about 2 to about40, from about 2 to about 30, from about 2 to about 20, or from about 2to about 15 vertically stacked holding structures or racks can be used.Referring to FIGS. 5A-5B and 17-20, in this configuration the detectionsystem 100 includes a climate controlled interior chamber 620,comprising an upper interior chamber 622 and a lower interior chamber624, and a plurality of vertically disposed holding structures or racks600 (e.g., as shown in FIGS. 5A-5B, 15 vertically stacked holdingstructures or racks 600) each having a plurality of individual containerreceiving structures or wells 602 therein. Each individual holdingstructure or rack 600 can comprise two or more container receivingstructures of wells 602. For example, each holding structure or rack 600can comprise from about 2 to about 40, from about 2 to about 30, or fromabout 2 to about 20 receiving structures of wells 602 therein. In oneembodiment, as shown in FIGS. 5A-5B, the receiving structures or wells602 can comprise 2 rows of vertically aligned receiving structures orwells 602. In an alternative embodiment, the receiving structures orwells 602 can be staggered, thus reducing the vertical height of eachindividual holding structure or rack 600 (see, e.g., FIG. 20), andthereby allowing for an increased number of total holding structures orracks 600 in a given vertical distance within the incubation chamber620. As shown, for example in FIGS. 5A-5B, the detection systemcomprises 15 holding structures or racks 600 each comprising two rows of10 individual container receiving structures or wells 602, therebygiving the system exemplified in FIGS. 5A-5B a total container capacityof 300. In another possible design configuration, the detectionapparatus may comprise 16 vertically stacked racks, each containing 25receiving structures or wells, thereby giving a total container capacityof 400.

Furthermore, each of the individual container receiving structures orwells 602 has a specific X and Y coordinate position or address, where Xis the horizontal location and Y is the vertical location of eachcontainer receiving structure or well 602. The individual wells 602 areaccessed by a transfer mechanism, such as a robotic transfer arm, forexample, as described hereinabove in conjunction with FIGS. 17-21). Asshown in FIGS. 17-21, the automated transfer mechanism 700 can operateto move the robotic head 710, and thus, the specimen container 500, to aspecific of the X, Y positions in the rack 600 and deposit the container500 therein. In operation, the automated transfer mechanism 700 canoperate to pick-up a specimen container 500 at the entrance station 110or the pick-up station 418 of the container locator device 400, move acontainer 500 determined positive for microbial growth therein to apositive container or exit location 130, and/or to move a container 500determined negative for microbial growth to a negative containerlocation or waste bin 146.

In one embodiment, the entire holding structure or rack 600 can beagitated by an agitation assembly (not shown) to promote or enhancemicroorganism growth. The agitation assembly can be any known means ormechanism for providing agitation (e.g., a back-and-forth rockingmotion) to the holding structures or racks 600. In another embodiment,the holding structures or racks 600 can be rocked in a back-and-forthmotion for agitation of the fluid contained within the containers. Forexample, the holding structures or racks 600 can be rockedback-and-forth from a substantially vertical position to a substantiallyhorizontal position, and repeated to provide agitation of the fluidcontained within the container. In yet another embodiment, the holdingstructures or racks 600 can be rocked back-and-forth from asubstantially horizontal position to a vertical position 10 degrees, 15degrees, 30 degrees, 45 degrees or 60 degrees from horizontal, andrepeated to provide fluid agitation within the containers. In oneembodiment, a racking motion from a substantially horizontal position toa vertical position from about 10 degrees to about 15 degrees fromhorizontal may be preferred. In still another embodiment, the holdingstructure or racks 600 can be rocked back-and-forth in a linear orhorizontal motion to provide agitation of the fluid contained within thecontainers. In this embodiment, the holding structures or racks 600 andreceiving structures or wells 602 can be orientated in a vertical, oralternatively in a horizontal position. Applicants have found that alinear or horizontal agitation motion, with the holding structures 600,and thus the receiving structures or wells 602 and specimen containers500, in a horizontal orientation can provide substantial agitation witha relatively minimum energy input. Accordingly, in some embodiments, ahorizontal holding structure or rack 600 orientation and a linear orhorizontal agitation motion, may be preferred. Other means of agitatingthe holding structures or racks 600, and thus, the fluid within specimencontainers 500 are contemplated and would be well understood by oneskilled in the art. These back-and-forth, liner and/or horizontalrocking motions can be repeated as desired (e.g., at various cyclesand/or speeds) to provide agitation of the fluid within the containers.

One possible design for the agitation assembly is shown in conjunctionwith FIG. 26. As shown in FIG. 26, the agitation assembly 626 comprisesone or more holding structures 600 comprising a plurality of holdingwells 602 for holding a plurality of specimen containers 500. Theagitation assembly 626 further comprises an agitation motor 628, aneccentric coupling 630, a first rotation arm 632, a second rotation armor linkage arm 634 and a rack agitation bearing assembly 636. Inoperation, the agitation motor 628 rotates the eccentric coupling 630 inan off-center motion thereby moving a first rotation arm 632 in anoff-center circular or off-center rotational motion. The off-centerrotational movement of the first rotation arm 632 moves a secondrotation arm or linkage arm 634 in a linear motion (as represented byarrow 635). The linear motion of the second rotation arm or linkage arm634 rocks the rack agitation bearing assembly 636 in a back-and-forthrocking motion, thereby providing a back-and-forth rocking agitationmotion (represented by arrow 638 of FIG. 26) to the holding structures600.

In another possible design configuration, as shown in FIGS. 9A and 9B,the detection system 100 may includes upper and lower holding structures800A and 800B in the form of cylindrical or drum structures containing amultitude of individual specimen container receiving structures or wells802 for receiving one of the containers 500. In this embodiment, thecylindrical or drum holding structures 800A, 800B each rotate about ahorizontal axis to thereby provide agitation of the containers 500. Inaccordance with this embodiment, each drum holding structure cancomprise from about 8 to about 20 rows (e.g., from about 8 to about 20,from about 8 to about 18, or from about 10 to 1 about 6 rows), eachcomprising from about 8 to about 20 container receiving structures orwells 802 (e.g., from about 8 to about 20, from about 8 to about 18, orfrom about 10 to about 16 receiving structures of wells 802).

As described hereinabove, an automated transfer mechanism 820 isincorporated into the detection system 100 of FIGS. 9A-9B in order tograsp or pick-up a container 500 from the entrance location or port 110,and move or transfer the container 500 to a give receiving structure orwell 802, of either the upper or lower drum holding structure 800, anddeposit the container 500 therein. The automated transfer mechanism 820in this embodiment can further operate to move a negative container 500to a waste bin 146, or can operate to move a positive container to thepositive container location 130, shown for example, in FIG. 1. Also, aspreviously described, the robotic head 820 of FIGS. 9A-9B can pick-up acontainer 500 from the entrance location or port 110 and load thecontainer 500 head-first (i.e., top portion 502 first) into thereceiving structures or wells 802 of the drum holding structures 800A,800B. This orientation exposes the bottom or base 806 of the container500 to a detection unit 810 which can read the sensor 514 located at thebottom of the container 500 to detect microbial or microorganism growthwithin the container.

As described elsewhere herein, positive and negative containers can beretrieved by the robotic transfer arm and transferred to other locationswithin the system. For example, a container determined “positive” formicrobial growth can be retrieved and transferred via the transfermechanism to a positive container location or port where a user ortechnician can easily remove the positive container. Similarly, acontainer determined “negative” for microbial growth after a designatedtime has passed can be transferred via the transfer mechanism to anegative container location or waste bin for disposal.

In one embodiment, the holding structure or rack 600 may furthercomprise a retention feature operable to hold or otherwise retain aspecimen container 500 in the receiving structures or wells 602 of therack 600. As shown in FIGS. 27A-27C, the retention device 860 comprisesa canted coiled spring 864 and a v-shaped holding plate 862. Inaccordance with this embodiment, by using a canted coiled spring 868,multiple points of the coiled spring contact the container surface toretain the bottle in the rack well 602. The coils of the canted spring864 are set at an angle relative to the vertical axis of the container,as shown in FIG. 27C, which shows exaggerated coils to demonstrate thecoil angle relative to the vertical axis of the container. However,typically the canted spring 864 is a tightly coiled spring. For examplethe canted spring 864 can be at an angel of about 10 degrees to about 50degrees, from about 20 degrees to about 40 degrees, or about 30 degree(as shown in FIG. 27C), relative to the vertical axis of the container.The v-shaped holding plate 862 is capable of holding and/or retainingsaid canted coiled spring 864 relative to, or adjacent to the holdingstructure 600. As shown, the holding plate 862 comprising a v-groovedretainer plate for retaining the canted coiled spring 864. The v-grooveretainer plate 864 prevents any movement of the spring 864 relative tothe container 500 and/or holding structure 600. Accordingly, unlike atraditional extension spring, which would typically contact a containerat a single point (e.g., a flat leaf spring), the canted coiled spring864 can be rigidly retained by the v-shaped groove 862 while the coilswill deflect under pressure. The use of a canted spring 864 allows theload to be spread out, thereby providing uniform deflection.

As shown, e.g., in FIGS. 27A and 27C, the receiving structures or wells602 further comprise one or more ribs 868. In one design possibility, asshown in FIG. 27C, two of these ribs 868 are located directly oppositethe canted coiled spring 864. These two ribs 868 form a groove thatfunctions to self-center the container 500 within the well 602 along avertical centerline (not shown). In operation, the canted coiled spring864 applies force to the container 500 wall, thereby holding orretaining the container securely within the well 602 of the rack 600. Inone embodiment, the two ribs 868 located opposite the coiled spring 864can be spaced from 30 degrees to about 90 degrees apart, or from about40 degrees to about 80 degrees apart. In another embodiment, the tworibs 868 located opposite the canted coiled spring 864 can be spacedabout 60 degrees apart. Also, as shown in FIG. 27C, the holdingstructure may comprise a first row and a second row of parallel holdingwells, the parallel holding rows being capable of, or operable for,holding a plurality of containers therein, and wherein the holdingstructure further comprises a first canted coiled spring locatedadjacent to the first row and a second canted coiled spring adjacent tothe second row, wherein each of the canted coiled spring are operablefor retaining the plurality of containers in said holding wells.

Using the canted coiled spring 864, v-groove retainer 862 and two ribs868 located opposite said canted coiled spring 864, the bottle willalways be held securely in the same location within the well 602,regardless of any sideloads applied through agitation or during rackcell insertion. The canted coiled spring 864 and v-groove retainer 862also allow for the use of a shorter depth holding well 602 and holdingstructure 600. The shorter holding well 602 depth will allow formultiple container designs and container lengths to be retained equallywell, as well as allow more of the container surface to be expose to theincubation air flow within the system.

As one of skill in the art would appreciate other possible designs orconfigurations for the holding structure or structures 600 and/oragitation assembly are possible and are considered part of presentinvention.

Detection Unit

The various possible design configurations of the detection system 100,as shown in FIGS. 1-6, 9A-9B, 21A-21B and 27, can include the use ofsimilar detection means. In general, any known means in the art formonitoring and/or interrogating a specimen container for the detectionof microbial growth can be used. As previously mentioned, the specimencontainers 500 can be monitored continuously, or periodically, duringincubation of the containers 500 in the detection system 100, for thepositive detection of microbial growth. For example, in one embodiment,a detection unit (e.g., 810 of FIG. 9B) reads the sensor 514incorporated into the bottom or base 506 of the container 500. A varietyof sensor technologies are available in the art and may suitable. In onepossible embodiment, the detection unit takes colorimetric measurementsas described in the U.S. Pat. Nos. 4,945,060; 5,094,955; 5,162,229;5,164,796; 5,217,876; 5,795,773; and 5,856,175, which are incorporatedherein. A positive container is indicated depending upon thesecolorimetric measurements, as explained in these patents. Alternatively,detection could also be accomplished using intrinsic fluorescence of themicroorganism, and/or detection of changes in the optical scattering ofthe media (as disclosed, for example, in co-pending U.S. patentapplication Ser. No. 12/460,607, filed Jul. 22, 2009 and entitled,“Method and System for Detection and/or Characterization of a BiologicalParticle in a Sample.”). In yet another embodiment, detection can beaccomplished by detecting or sensing the generation of volatile organiccompounds in the media or headspace of the container. Various designconfigurations for the detection unit can be employed within thedetection system. For example, one detection unit could be provided foran entire rack or tray, or multiple detection units could be providedper rack or per tray.

Climate-Controlled Interior Chamber

As previously described, the detection system 100 may include aclimate-controlled interior chamber (or incubation chamber), formaintaining an environment to promote and/or enhance growth of anymicrobial agents (e.g., microorganisms) that may be present in thespecimen container 500. In accordance with this embodiment, thedetection system 100 may include a heating element or hot air blower tomaintain a constant temperature within said interior chamber. Forexample, in one embodiment, the heating element or hot air blower willprovide and/or maintain the interior chamber at an elevated temperature(i.e., a temperature elevated above room temperature). In anotherembodiment, the detection system 100 may include a cooling element orcold air blower (not shown) to maintain the interior chamber at atemperature below room temperature. In accordance with this embodiment,the interior chamber or incubation chamber will be at a temperature offrom about 18° to about 45° C. In one embodiment, the interior chambercan be an incubation chamber and can be maintained at a temperature fromabout 35° C. to about 40° C., and preferably at about 37° C. In anotherembodiment, the interior chamber may be maintained at a temperaturebelow room temperature, for example from about 18° C. to about 25° C.,and preferably at about 22.5° C.. A particular advantage provided is theability to provide a more constant temperature environment for promotingand/or enhancing microbial growth within a specimen container 500. Thedetection system 100 accomplishes this by providing a closed system, inwhich automated loading, transfer and unloading of specimen containers500 occurs without the need to open any access panels that wouldotherwise disrupt the incubation temperature (from about 30° to 40° C.,preferably from about 37° C.) of the interior chamber 620.

In general, the detection system 100 can employ any known means in theart for maintaining a climate-controlled chamber for promoting orenhancing microbial growth. For example, to maintain a temperaturecontrolled chamber, one or more heating element or hot air blower,baffles and/or other suitable equipment known in the art, can be used tomaintain the interior of the detection system 100 at the appropriatetemperature for incubating the container and promoting and/or enhancingmicrobial growth.

Typically, one or more heating element or hot air blower under controlof the system controller are used to maintain a constant temperaturewithin the interior chamber 620 of the detection system 100. As known inthe art, the heating element or hot air blower can be employed in anumber of locations within the interior chamber. For example, as shownin FIGS. 5 and 6 one or more heating elements or hot air blowers 740 canbe positioned at the base of the holding structures or racks 600, fordirecting warm air across the plurality of holding structures or racks600. A similar arrangement can be provided in the embodiments of FIGS.9A and 9B (see, e.g., 840). The details of the incubation features arenot particularly pertinent, and are known in the art, therefore adetailed description is omitted.

Controller and User Interface

The detection system 100 will include a system controller (e.g., acomputer control system) (not shown) and firmware for controlling thevarious operations and mechanisms of the system. Typically, the systemcontroller and firmware for controlling the operation of the variousmechanisms of the system can be any known conventional controller andfirmware known to those of skill in the art. In one embodiment, thecontroller and firmware will performs all operations necessary forcontrolling the various mechanisms of the system, including: automatedloading, automated transfer, automated detection and/or automatedunloading of specimen containers within the system. The controller andfirmware will also provide for identification and tracking of specimencontainers within the system.

The detection system 100 may also include a user interface 150 andassociated computer control system for operating the loading mechanism,transfer mechanism, racks, agitation equipment, incubation apparatus,and receiving measurements from the detection units. These details arenot particularly important and can vary widely. When a container isdetected as being positive, the user can be alerted via the userinterface 150 and/or by the positive indicator 190 (see, e.g., FIG. 1)becoming active (i.e., an indicator light turning on). As describedherein, upon a positive determination, the positive container can beautomatically moved to a positive container location 130, shown forexample in FIGS. 1-3, 10-11 and 22-24 for retrieval by a user.

The user interface 150 may also provide an operator or laboratorytechnician with status information regarding containers loaded into thedetection system. The user interface may includes one or more of thefollowing features: (1) Touch screen display; (2) Keyboard on touchscreen; (3) System status; (4) Positives alert; (5) Communications toother systems (DMS, LIS, BCES & other detection or identificationInstruments); (6) Container or bottle status; (7) Retrieve containers orbottles; (8) Visual and audible Positive Indicator; (9) USB access (backups and external system access); and (10) Remote Notification ofPositives, System Status and Error Messages. In another embodiment, asshown in FIGS. 22-23, a status update screen 152 can also be used. Thestatus update screen 152 can be used to provide status informationregarding containers loaded into the detection system, such as, forexample: (1) container location within the system; (2) containerinformation, such as, patient information, sample type, input time,etc.; (3) positive or negative container alerts; (4) interior chambertemperature; and (5) an indication that the waste bin is full and needsto be emptied.

The particular appearance or layout of the detection system and userinterface 150, and/or status update screen 152, is not particularlyimportant, and can vary widely. FIGS. 1-2 show one possible embodiment,which is provided by way of illustration and not limitation. FIGS. 22-23show another possible embodiment, which is also provided by way ofillustration and not limitation.

Automated Unloading

The detection system 100 may also provide for automated transfer orautomated unloading of “positive” and “negative” specimen containers500. As previously described, containers in which a microbial agent ispresent are termed “positive” containers, and containers in which nomicroorganism growth is detected after a given time period are termed“negative” containers.

Once a container is detected as positive, the detection system willnotify the operator of the results through an indicator (e.g. visualprompt 190) and/or through notification at the user interface 150.Referring now to FIGS. 1-3 and 5A-5B, positive bottles can beautomatically retrieved via the transfer mechanism 650 (e.g., robotictransfer arm) and placed in a designated positive container area, suchas a positive container location or exit port 130. This positivecontainer area will be located outside of the instrument housing foreasy user access to the container. In a one embodiment, the containerwill be placed in a vertical orientation within the positive containerarea. In one design configuration, the automated unloading of a positivecontainer will employ the use of a transfer tube (not shown) throughwhich a positive container (e.g., a positive blood culture bottle) cantravel to be relocated to a designated positive container location orexit port 130. In accordance with this design feature, the transfermechanism (e.g., the robotic transfer arm) will drop or otherwisedeposit the positive specimen container into a top end of the transfertube, and the container will travel through the transfer tube viagravity to the positive container location or port 130. In oneembodiment, the transfer tube (not shown) can hold one or more“positive” specimen containers therein. For example, the transfer tube(not shown) can hold from about 1 to about 5, from about 1 to about 4,or from about 1 to about 3 “positive” specimen containers. In anotherembodiment, for example as shown in FIGS. 22-24, the positive containerlocation or exit port 130 may comprise holding wells for one or more“positive” specimen containers, for example, two holding wells forseparately holding two “positive” specimen containers.

In another embodiment of the detection system 100, negative containerscan be transferred by the transfer mechanism 700 (e.g., robotic transferarm) from the holding structure or rack 600 to a negative containerlocation, such as a waste bin 146. Typically, the containers will bereleased from the robotic transfer arm and dropped into the waste bin146, however other embodiments are contemplated and should be apparentto one of skill in the art. In one design configuration, the automatedunloading of a negative container will employ the use of a transfer tube(not shown) through which a negative container (e.g., a negative bloodculture bottle) can travel to be relocated to a designated negativecontainer location, such as a waste bin 146. In accordance with thisdesign feature, the transfer mechanism (e.g., the robotic transfer arm)will drop or otherwise deposit the negative specimen container into atop end of the transfer tube, and the container will travel through thetransfer tube via gravity to the negative container location or wastebin 146. The detection system 100 may also include an access door 140 ordrawer 142 that opens to provide user access to the negative containerlocation, such as a negative container waste bin 146. In anotherembodiment, the waste bin 146 may include a scale to weigh the waste bin146. As one of skill in the art would appreciate, by monitoring theweight of the waste bin 146, the system controller (not shown) candetermine how full the waste bin 146 is, and can optionally provide asignal (e.g., at the user interface 150) indicating to the user ortechnician that the waste bin 146 is full, and thus, needs to beemptied.

Automated Laboratory System

As noted above, the detection system 100 of this disclosure can take ona variety of different possible configurations. One such configuration,particularly suited for high volume implementations, is shown in FIG.24. As shown in FIG. 24, the detection system 100A can be employed in anautomated microbiology laboratory system. For example, the detectioninstrument 100 can be included as one component of an automatedlaboratory system. In this embodiment, the detection instrument 100A canbe linked or “daisy chained” to one or more additional other analyticalmodules or instruments for additional testing. For example, as shown inFIG. 24, the detection instrument 100A can be linked or “daisy chained”to a second detection unit 100B. However, in other embodiments, thedetection instrument can be “daisy chained” or otherwise linked to oneor more other systems or modules. These other systems or modules caninclude, for example, identification testing systems such as the VITEKor VIDAS systems of the assignee bioMérieux, Inc., a gram stainer, amass spectrometry unit, a molecular diagnostic test system, a platestreaker, an automated characterization and/or identification system (asdisclosed in co-pending U.S. patent application No. 60/216,339, entitled“System for Rapid Non-invasive Detection of a Microbial Agent in aBiological Sample and Identifying and/or Characterizing the MicrobialAgent”, which was filed May 15, 2009) or other analytical systems.

Referring now to FIG. 24, an automated laboratory system can comprise afirst detection system 100A, and a second detection system 100B. Inother embodiments, the automated laboratory system can comprise a firstdetection system 100A, a second detection system 100B, and an automatedcharacterization/identification system (not shown). In accordance withthis embodiment, positive containers can be moved or transferred fromthe first detection system 100A to the second detection system 100B,and/or subsequently to the automated characterization/identificationsystem, using a system transfer device 440. In other embodiments, thefirst detection system 100A can be coupled to a microorganismidentification module or an antimicrobial susceptibility module (notshown).

The system transfer device or mechanism for transferring a containerfrom a first instrument to a second instrument may comprise: (a)providing a first instrument, a second instrument, and a containerlocated within said first instrument; (b) a first locator device coupledto said first instrument and operable for moving said container to oneor more work-flow stations; (c) a transport mechanism or conveyor beltcoupled to said second instrument and located juxtaposed to said firstlocator device; and (d) a pusher arm operable to move or push saidcontainer from said first locator device to said transport mechanism andthereby transferring said container from said first instrument to saidsecond instrument. In another embodiment, the first and secondinstruments can be culture instruments and the container can be aspecimen container. In yet another embodiment, the transport mechanismcomprises a first transport mechanism or conveyor belt coupled to saidfirst instrument, a first locator device coupled to said firstinstrument, a second transport mechanism or conveyor belt coupled tosaid second instrument, a second locator device coupled to said secondinstrument, and a pusher arm for transferring a container from saidfirst locator device to said second transport mechanism or conveyor beltthereby transferring said container from said first instrument to saidsecond instrument. In still a further embodiment, the transfer mechanismmay comprises a transfer bridge coupled to said first and said secondinstruments thereby coupling or linking the first and secondinstruments. The transfer bridge will comprise a first end locatedjuxtaposed to said first locator device and a second end locatedjuxtaposed to said second transport mechanism or conveyor belt. Thetransfer bridge links the first instrument and the second instrument andprovides a mechanism or means for transferring a container from thefirst instrument to the second instrument. Accordingly, in thisembodiment, the transfer mechanism may further comprises a transferbridge linking said first instrument to said second instrument, whereinsaid transfer bridge comprises a first end located juxtaposed to saidfirst locator device and a second end located juxtaposed to said secondtransport mechanism, thereby linking said first locator device and saidsecond transport mechanism, and wherein said pusher arm is operable topush said container across said transfer bridge, thereby transferringsaid container from said first instrument to said second instrument.

As shown in FIGS. 24-25C two detection systems 100A and 100B are “daisychained” together by system transfer device 441. This allows containersto be transferred from one detection system to another in case the firstone is full. A similar system transfer device may also be provided forsubsequent transfer of the specimen container 500 from the seconddetection system 100B to a subsequent systems or modules, as describedelsewhere herein. The system transfer mechanism 441 comprises a firstcontainer locator device 400A having a transfer station 420 fortransferring a container to a second or downstream instrument. Thesystem transfer mechanism 441 also comprises a pusher arm 444 operablecontrolled by a pusher motor 442 and a transfer bridge 446, as shown inFIG. 24-25C. As shown, the pusher arm 444 may comprise a pair ofparallel arms. In operation, when a container to be transferred is movedby the transfer station 420 of the first container locator device 400A,a pusher arm 444 is activated to push or move the container from thetransfer station 420, across a transfer bridge 446, to the down-streamdetection system 100B. As shown, the pusher arm 444 is connected to apusher motor 442 via a pusher arm support structure 445. FIGS. 25A-Cshow the transfer of a container from the transfer station 420 of thefirst detection system 100A to the conveyor belt 206B (see FIG. 24) ofthe second detection system 100B, and show the container in: (1) a firstposition (FIG. 25A) as the pusher arm 444 begins to push the containeracross the transfer bridge 446; (2) a second or intermediate position(FIG. 25B) as the container crosses the transfer bridge 446; and (3) afinal position (FIG. 25C) as the container arrives at the conveyor belt(not shown) of the down-stream detection system 100B. Furthermore, asshown in FIGS. 25A-25C, the system transfer device 440 may furthercomprise one or more locator device guide rails 450 attached to a baseplate of the locator device 404 via one or more guide rail supports 452,and/or bridge guide rails 446, 448, to guide the container from thefirst locator device 400A and across the bridge 446 to the conveyor belt206B (see FIG. 24) of the automated loading mechanism 200B of thedown-stream detection system 100B. As would be well known in the art,the transfer of a container from the first detection system 100A to thesecond or down-stream detection system 100B, via the operation of thefirst container locator device 400A and pusher arm 444, can becontrolled by the system controller. Typically, as shown in FIG. 24,only the first detection system 100A needs to include a user interface150. The first 100A and second 100B detection systems may furthercomprise status screens 152A, 152B, positive container ports 130A, 130B,lower access panels 140A, 140B, automated loading mechanisms 200A, 200Band conveyor belts 206A, 206B.

Further, in accordance with this embodiment, positive containers can betransferred to other systems in the automated laboratory system. Forexample, as shown in FIG. 24, a container determined positive in thefirst detection system 100A can be transferred to the second detectionsystem 100B and/or subsequently to an automatedcharacterization/identification system (not shown) for automatedcharacterization and/or identification of the microbe therein.

As one of skill in the art would appreciate other possible designs orconfigurations for the automated laboratory system are possible and areconsidered part of this invention.

Method of Operation

In one embodiment, a method for detection of microorganism growth in anautomated detection system is described herein; the method comprising:(a) providing a specimen container comprising a culture medium forpromoting and/or enhancing growth of said microorganism; (b) inoculatingsaid specimen container with a test sample to be tested for the presenceof a microorganism; (c) loading said inoculated specimen container intosaid detection system using an automated loading mechanism; (d)transferring said specimen container to a holding structure locatedwithin said detection system using an automated transfer mechanism, saidholding structure comprising a plurality of wells for holding one ormore of said specimen containers; and said holding structure optionallyproviding agitation of said specimen containers to promote and/orenhance microorganism growth therein; (e) providing a detection unit fordetecting microbial growth in said specimen container by detecting oneor more by products of microorganism growth within said container; and(f) detecting growth of a microorganism using said detection unit andthereby determining said container positive for microorganism growth.

The method of operation of the detection system 100 will now bedescribed with reference to FIG. 30. After inoculation of a specimencontainer 500 with a sample to be tested (e.g., by a laboratorytechnician or doctor) the specimen container 500 is delivered to theautomated loading mechanism 200, for automated loading of the specimencontainer 500 into the detection system 100.

At step 540, the specimen container 500 is loaded into the detectionsystem 100, e.g., by placing the container onto a loading station orarea 202 of a transport mechanism 204, as shown for example in FIG. 1.The specimen container 500 is then moved by the transport mechanism 204(e.g., a conveyor belt) to an entrance location or port 110, andsubsequently through said entrance location or port 110 and into thedetection system 100, thereby automatically loading the specimencontainer 500 into the detection system 100.

At step 550, an automated transfer mechanism 700, such as a robotictransfer arm, as shown for example in FIGS. 5A-5B, can then be used totransfer the container 500 to, and deposit the container in, a holdingstructure or rack 600 contained within the interior chamber 620 of thedetection system 100.

At step 560, the specimen container 500 is incubated within thedetection system 100. The detection system 100 optionally provides foragitation (e.g., using an agitation assembly) of the holding structuresor racks 600, and/or one or more warm air blowers (see, e.g., 740 inFIGS. 5A-5B) to provide a temperature controlled environment, to promoteand/or enhance microbial growth within the specimen container 500.

At step 570, the specimen container 500 is read by a detection unit(see, e.g., 810 in FIGS. 9A and 9B) to determine if the specimencontainer 500 is positive for microbial growth.

At step 580, the reading of the specimen container is analyzed todetermine if the container is positive for the growth of a microbialagent (e.g., a microorganism) therein. If not, the processing proceedsalong the NO branch 582 and a check is made if a timer has expired (step584). If the timer has expired, the container is deemed negative and thecontainer is transferred to the waste container 146 (see for exampleFIG. 1) at step 586. Otherwise, the incubation continues and the readingof the specimen container 500 (step-580) continues periodically.

If at step 580, if the specimen container 500 is determined to bepositive, the processing proceeds to the YES branch 590. In oneembodiment, the specimen container 500 is moved or transferred using theautomated transfer mechanism (e.g., the container is automaticallyunloading, as described elsewhere herein) to the positive containerlocation or port 130 (see for example FIG. 1) at step 594 for useraccess to the container and/or further processing. In anotherembodiment, the specimen container can be transferred using a systemtransfer device to another detection instrument and/or anotheranalytical system (e.g., to an automated characterization and/oridentification system) for further processing.

1. An automated detection apparatus for rapid non-invasive detection ofmicroorganism growth in a test sample, comprising: (a) providing asealable specimen container having an internal chamber with a culturemedium disposed therein for culturing any microorganisms that may bepresent in said test sample; (b) a housing enclosing an interiorchamber; (c) a holding structure contained within said interior chamberand comprising a plurality of wells for holding one or more of saidspecimen containers; (d) a container locator device, and wherein saidcontainer locator device is operable to move said specimen container toone or more container work-flow stations; (e) an automated loadingmechanism for automated loading of a specimen container into saidinterior chamber; and (f) an automated transfer mechanism located withinsaid interior chamber for the automated transfer of said specimencontainer within said interior chamber; and (g) a detection unit locatedwithin said interior chamber for the detection of microorganism growthin said specimen container.
 2. The automated detection apparatus ofclaim 1, wherein said automated detection system further comprises anautomated unloading mechanism for the automated unloading of saidspecimen container from said detection apparatus.
 3. The automateddetection apparatus of claim 2, wherein said automated unloadingmechanism transfers a specimen container detected as positive formicroorganism growth to a positive container location.
 4. The automateddetection apparatus of claim 2, wherein said automated unloadingmechanism transfers a specimen container detected as negative formicroorganism growth to a negative container location.
 5. The automateddetection apparatus of claim 2, wherein said automated unloadingmechanism is said automated transfer mechanism.
 6. The automateddetection apparatus of claim 1, wherein said automated transfermechanism comprises a robotic transfer arm, and wherein said robotictransfer arm comprises a multi-axis robotic transfer arm.
 7. Theautomated detection apparatus of claim 1, wherein said holding structureis selected from the group consisting of: a plurality of stacked racksand one or more cylindrical drum.
 8. The automated detection apparatusof claim 1, wherein said holding structure further comprises anagitation assembly for the agitation of said specimen container topromote and/or enhance microorganism growth therein.
 9. The automateddetection apparatus of claim 1, wherein said interior chamber comprisesan incubation chamber, said incubation chamber comprising one or moreheating elements to provide and/or maintain a climate-controlledinterior chamber for promoting and/or enhancing microorganism growththerein.
 10. The automated detection apparatus of claim 10, wherein saidclimate-controlled interior chamber is maintained at a temperature offrom about 30° C. to about 40° C.
 11. The automated detection apparatusof claim 11, wherein said one or more workstations are selected from thegroup consisting of a bar code reading station, a container scanningstation, a container imaging station, a container weighing station, acontainer pick-up station, a container transfer station, or acombination thereof.
 12. The automated detection apparatus of claim 1,wherein said automated loading mechanism comprises a container loadingstation, a transport mechanism, and a container entrance location,wherein said transport mechanism is operable to transport said specimencontainer from said loading station to said entrance location forautomated loading of said specimen container into said detectionapparatus.
 13. The automated detection apparatus of claim 1, whereinsaid transport mechanism comprises a conveyor belt.
 14. The automateddetection apparatus of claim 1, wherein said detection apparatus furthercomprises a bar code reader.
 15. The automated detection apparatus ofclaim 1, wherein said detection apparatus further comprises acontroller, and wherein said controller is operable to control saidautomated loading mechanism, said container locator device and/or saidautomated transfer mechanism, thereby providing for a fully automateddetection apparatus for rapid non-invasive.
 16. The automated detectionapparatus of claim 15, wherein said controller signals a specimencontainer detected as positive for microorganism growth with a positiveindicator prompt on said housing.
 17. A method for the detection ofmicroorganism growth in an automated detection apparatus, said methodcomprising the following steps: (a) providing a specimen containercomprising a culture medium for promoting and/or enhancing growth ofsaid microorganism; (b) inoculating said specimen container with a testsample to be tested for the presence of a microorganism; (c) providingan automated detection apparatus for the detection of microorganismgrowth, said apparatus comprising: (i) a housing enclosing an interiorchamber therein; (ii) a holding structure located within said housing,said holding structure comprising a plurality of wells for holding oneor more of said specimen containers; (iii) an automated loadingmechanism for automated loading of said specimen container into saidautomated detection apparatus; (iv) a container locator device formoving said specimen container to one or more container work-flowstations; (v) an automated transfer mechanism for automated transfer ofsaid specimen container within said housing to said holding structure;and (vi) a detection unit for detecting one or more by products ofmicroorganism growth within said specimen container; and (d) loadingsaid inoculated specimen container into said detection apparatus usingsaid automated loading mechanism; (e) transferring said inoculatedspecimen container to said holding structure located within saiddetection apparatus using said automated transfer mechanism; (f)incubating said specimen container within said incubation chamber; and(g) periodically monitoring said specimen container for detection ofsaid one or more by products of microorganism growth, wherein saidspecimen container is determined as positive for microorganism growth bythe detection of said one or more by products of microorganism growththerein.
 18. The method of claim 17, wherein said interior chambercomprises an incubation chamber said incubation chamber comprising oneor more heating elements to provide and/or maintain a climate-controlledinterior chamber for promoting and/or enhancing microorganism growththerein.
 19. The method of claim 17, wherein said interior chambercomprises a cooling chamber said cooling chamber comprising one or morecooling elements for maintaining said cooling chamber at a temperaturebelow room temperature.
 20. The method of claim 17, wherein saidautomated detection system further comprise a container locator deviceoperable to move said specimen container among one or more work stationsfor obtaining one or more measurements or readings of the specimencontainer, and wherein said method further comprise as step (d)(1)moving said specimen container among one or more work stations usingsaid container locator device.
 21. The method of claim 20, wherein saidone or more work stations are selected from the group consisting of abar code reading station, a container scanning station, a containerimaging station, a container weighing station, a container pick-upstation, a container transfer station, or a combination thereof.
 22. Themethod of claim 20, wherein said step (d)(1) comprises moving saidspecimen container to a pick-up station, and wherein said method furthercomprises as step (d)(2) picking-up said specimen container from saidpick-up station using said automated transfer mechanism.
 23. The methodof claim 17, wherein said detection apparatus further comprises anagitation assembly operable for agitation of said holding structure andsaid specimen container to promote and/or enhance microorganism growththerein, and wherein said method further comprise as step (e)(1)agitating said holder structure using said agitation assembly.
 24. Themethod of claim 18, wherein said automated detection system furthercomprises an automated unloading mechanism for automated unloading ofsaid specimen container, and wherein said method further comprises asstep (h) transferring a specimen container detected as positive formicroorganism growth to a positive container location using saidautomated unloading mechanism.
 25. The method of claim 17, wherein saidautomated detection system further comprises an automated unloadingmechanism for automated unloading of said specimen container, andwherein said method further comprises as step (h) transferring aspecimen container detected as negative for microorganism growth to anegative container location using said automated unloading mechanism.26. The method of claim 17, wherein said automated detection systemfurther comprises a controller, and wherein said controller is operableto control one or more steps of said method.
 27. A retention feature forretaining a container in a holding structure, comprising: a) provided aholding structure comprising one or more holding wells for holding oneor more containers therein; b) a canted coiled spring located adjacentsaid holding wells; and c) a holding plate comprising a v-shaped groovelocated adjacent said canted coiled spring for retaining said cantedcoiled spring adjacent to said holding wells; and wherein said cantedcoiled spring is operable to hold said one or more containers in saidholding well.
 28. The retention feature of claim 27, wherein saidholding wells further comprise one or more ribs, and wherein said one ormore ribs comprise a pair of ribs orientated in said holding wellopposite said canted coiled spring, and wherein said pair of ribs areoperable to self-align said container within said well along a verticalcenterline of said holding well.
 29. The retention feature of claim 27,wherein said holding structure comprises a first row and a second row ofparallel holding wells, said parallel holding rows capable of holding aplurality of containers therein, and wherein said holding structurefurther comprises a first canted coiled spring located adjacent to saidfirst row and a second canted coiled spring adjacent to said second row,wherein each of said canted coiled spring are operable for retainingsaid plurality of containers in said holding wells.
 30. The retentionfeature of claim 29, wherein said holding structure further comprises afirst holding plate located adjacent to said first canted coiled springand a second holding plate located adjacent to said second canted coiledspring, wherein said first and said second holding plates are operablefor holding said first and said second canted coiled springs,respectively, adjacent to said holding wells for holding a plurality ofsaid containers in said wells.